Oncology

Boehringer buys Abexxa, bolstering its immuno-oncology pipeline

Boehringer Ingelheim says it has agreed to buy US biotech Abexxa Biologics, its second acquisition in the cancer immunotherapy area in the space of a year. Texas-based Abexxa has been on the Boehringer’s radar since it was set up, as it provided seed funding for the preclinical-stage company in 2016, buying into its approach of …

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FDA clears AI-powered prostate cancer detection software

Software that can help pathologists detect prostate cancer from slides of biopsies more effectively has been approved by the FDA. The software – called Paige Prostate – is the first artificial intelligence-based to be approved by the FDA for this purpose, according to the US regulator. It is used to screen for signs of cancer …

FDA clears AI-powered prostate cancer detection software Read More »

FDA clears Seagen, Genmab’s Tivdak ADC for cervical cancer

Antibody-drug conjugate (ADC) specialist Seagen has claimed its fourth product approval in the US, getting the nod from the FDA for Tivdak as a second-line monotherapy for recurrent or metastatic cervical cancer. The accelerated approval for Tivdak (tisotumab vedotin) is for women whose cancer has progressed on or after first-line chemotherapy, according to the two …

FDA clears Seagen, Genmab’s Tivdak ADC for cervical cancer Read More »

ESMO21: Libtayo extends survival in first-line NSCLC, challenging Keytruda

There’s no shortage of cancer immunotherapies trying to knock Merck & Co’s Keytruda off the top of the tree in previously-untreated non-small cell lung cancer (NSCLC). Sanofi and Regeneron have reported new data for Libtayo that suggests the drug could be a contender. Libtayo (cemiplimab) given in combination with chemotherapy looks broadly to have matched …

ESMO21: Libtayo extends survival in first-line NSCLC, challenging Keytruda Read More »

ESMO21: Enhertu brings it’s A game to second-line breast cancer

AstraZeneca and Daiichi Sankyo were clearly excited by data from a trial pitting their HER2 antibody-drug conjugate (ADC) Enhertu against Roche’s rival Kadcyla when they reported top-line results last month – and a look at the full data set reveals why. In the DESTINY-Breast03 trial, Enhertu (trastuzumab deruxtecan) reduced the risk of disease progression or …

ESMO21: Enhertu brings it’s A game to second-line breast cancer Read More »

ESMO21: Roche’s giredestrant takes stage in battle of the oral SERDs

Roche has revealed the first phase 2 clinical data with giredestrant, one of a clutch of new selective oestrogen receptor degraders (SERDs) hoping to provide an oral alternative to AstraZeneca’s injectable Faslodex for breast cancer. The Swiss drugmaker presented results from its coopERA trial of giredestrant in post-menopausal women with hormone receptor (HR)-positive, HER2-negative early …

ESMO21: Roche’s giredestrant takes stage in battle of the oral SERDs Read More »

Keytruda backed by NICE for late-stage oesophageal cancer

MSD’s Keytruda has become the first immunotherapy cleared by NICE for previously-untreated patients with advanced oesophageal cancer, making it an option for routine NHS treatment. Keytruda (pembrolizumab) has been given the green light for use alongside platinum- and fluoropyrimidine-based chemotherapy in patients with locally advanced or metastatic oesophageal cancer that cannot be treated with surgery. …

Keytruda backed by NICE for late-stage oesophageal cancer Read More »

ESMO21: First combo data with Amgen’s Lumakras hit the mark in CRC

Amgen has made progress with its plans to expand the use of its first-in-class KRAS inhibitor Lumakras, reporting encouraging results when the drug is used alongside its EGFR drug Vectibix in colorectal cancer (CRC). The phase 2 study due to be reported at the ESMO cancer meeting – in patients KRAS G12c-mutated CRC – is …

ESMO21: First combo data with Amgen’s Lumakras hit the mark in CRC Read More »

Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval

Takeda has had a run of bad luck with its Wave1 pipeline of new drug candidates of late, but can now celebrate a vestry after getting FDA approval for first-in-class lung cancer therapy Exkivity. The US regulator has cleared the tyrosine kinase inhibitor (TKI) as a second-line treatment for locally advanced or metastatic non-small-cell lung …

Takeda gets a win for its Wave1 pipeline, as Exkivity nabs FDA approval Read More »

Assessing the Opportunities and Challenges in the Oncology Segment

Oncology is the study of cancer and encompasses the diagnosis and treatment of cancer. The treatment of cancer requires a multidisciplinary approach which includes medications, surgical, and radiation. The type of approach adopted depends upon the stages, age, and the patient’s preference. Cancer encompasses a group of diseases, which can affect any organ or tissue …

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Evaluating the Present and Future Oncology Market Outlook With Valued Research and Analysis

Oncology deals with the diagnosis and treatment of cancer. It is one of the most dynamic segments moving at a rapid pace in terms of research and development activities, diagnostics, and treatment. Oncology encompassed several diseases (or indications). Oncology Based Indications are further classified as Blood cancer, Solid tumors, and Lymphomas.  Over the past few …

Evaluating the Present and Future Oncology Market Outlook With Valued Research and Analysis Read More »

Rome Therapeutics raises $77m for junk DNA-targeting drugs

Startup Rome Therapeutics has raised $77 million in second-round financing to help mine sequences of DNA – which were dismissed for years as ‘junk’ – for hidden treasure. The Cambridge, Massachusetts biotech is focusing specifically on the 60% of DNA sequences that repeat themselves hundreds or thousands of times in the genome, known as the …

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First FDA filing for Novartis’ latecomer PD-1 drug tislelizumab

Novartis has filed for FDA approval of tislelizumab – a PD-1 inhibitor licensed from Chinese biotech BeiGene earlier this year – as a second-line treatment for oesophageal cancer. The Swiss pharma giant licensed ex-China rights to tislelizumab in February for $650 million upfront ad up to $1.55 billion in milestones, shortly after its own PD-1 …

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NHS England starts largest ever trial of Galleri cancer blood test

A blood test called Galleri that could detect dozens of different forms of cancer before symptoms appear will start trials by the NHS in England involving around 140,000 subjects. Volunteers aged between 50 and 77 are being sought to trial the diagnostic developed by California biotech Grail, which spun out of Illumina in 2016 and …

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NHS fast tracks access to Amgen’s just-approved KRAS cancer drug

Amgen’s first-in-class KRAS inhibitor Lumykras has been approved in Great Britain and arrives already armed with an agreement to allow early access while its cost-effectiveness is appraised by NICE. The MHRA has approved Lumykras (sotorasib) for patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with the KRAS G12C mutation, and …

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Cedars-Sinai Cancer Launches ‘Molecular Twin’ Initiative for Precision Cancer Treatment

What You Should Know: – Cedars-Sinai Cancer and Tempus, a provider of artificial intelligence and precision medicine, are harnessing the power of big data and AI to design personalized cancer treatment options by creating virtual replicas of patients’ DNA, RNA, protein and other information to help identify the most effective approach to each individual’s disease. …

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Biotech Insight podcast: Overcoming planning challenges in oncology

The first episode of Kantar Health’s new Biotech Insight podcast takes aim at the planning and forecasting challenges that biotechnology companies face, with a particular focus on oncology. Joining Dominic Tyer for this instalment of Biotech Insight are Prithu Somani, senior manager of forecasting and business analytics at Genmab, and Kantar Health’s vice president of …

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AI ‘could help diagnose lung cancer a year earlier’

An artificial intelligence algorithm was able to detect signs of lung cancer on CT scans a year earlier than with traditional methods, according to a new study. CT (computed tomography) scans are already used to spot signs of lung tumours, followed by a biopsy or surgery to confirm whether the tumour is malignant, according to …

AI ‘could help diagnose lung cancer a year earlier’ Read More »

NICE changes its mind on J&J’s Erleada in prostate cancer

NICE has reversed its position on Johnson & Johnson’s oral prostate cancer therapy Erleada in patients with hormone-relapsed or hormone sensitive tumours, backing NHS use of the drug. The change of heart comes after J&J’s Janssen pharma unit offered an improved discount on Erleada (apalutamide), according to the cost-effectiveness watchdog in its final appraisal determination, …

NICE changes its mind on J&J’s Erleada in prostate cancer Read More »

Roche dives further into cancer cell therapy with Adaptimmune deal

Roche has largely been a spectator on the side lines as other drugmakers have embraced cell therapies for cancer, but it has made a big play now, pledging $150 million upfront to an alliance with Adaptimmune Therapeutics. The Swiss drugmaker is backloading the five-year deal with around $3 billion in milestones, as the two companies …

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Gamble by Takeda on unproven cancer mechanism draws a blank

Takeda says a phase 3 trial of its cancer candidate pevonedistat – a class-leading NEDD8-activating enzyme inhibitor – has failed to show a benefit in patients with blood cancers, placing its future in doubt. The PANTHER trial looked at the combination of pevonedistat in combination with azacitidine chemotherapy as first-line treatment for patients with higher-risk …

Gamble by Takeda on unproven cancer mechanism draws a blank Read More »

Targeting COVID-19 and cancer with immunotherapy advancements

Anna Biosciences’ Dr Anthony Rullo discusses the drug development company’s immunotherapy platform. Over the last 30 years, we have seen dramatic improvements in patient outcomes due to the emergence of biologics – particularly monoclonal antibodies – as therapies for a wide variety of diseases and infections. Monoclonal antibodies (mABs) are highly specific therapies associated with …

Targeting COVID-19 and cancer with immunotherapy advancements Read More »

How pharma can help the post-COVID recovery of European cancer care

The new Cancer Care in Europe: Recovering from COVID-19 Disruption white paper assesses the disruption to patient care and the changes physicians implemented during the acute phase of the pandemic, with a focus on the way in which treatment strategies were altered. The publication, which has been supported by Accord Healthcare, also provides a series of …

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Ontada, Merck Partner to Facilitate Real World Evidence Studies for Cancer Care

What You Should Know: – Ontada, McKesson’s oncology and insights business, announced a strategic agreement with Merck, known as MSD outside the United States and Canada, that will facilitate the development of real-world research excellence and innovation. This agreement enables the two healthcare leaders to harness the power of real-world evidence (RWE) towards the common …

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Incyte, MorphoSys’ CAR-T rival tafasitamab approved in EU

Incyte and MorphoSys’ antibody therapy tafasitamab has been approved in Europe, promising to provide a more convenient alternative to expensive and cumbersome CAR-T therapies for patients with certain types of lymphoma. The European Commission has approved tafasitamab in combination with Bristol-Myers Squibb’s Revlimid (lenalidomide), followed by the antibody on its own, for the treatment of …

Incyte, MorphoSys’ CAR-T rival tafasitamab approved in EU Read More »

J&J lung cancer initiative will use Optellum’s ‘digital biomarker’ tech

Three years ago, Johnson & Johnson set up a wide-ranging initiative with Boston University to try to improve lung cancer survival rates through prevention and early intervention. Now, its calling on artificial intelligence specialist Optellum to help with that effort. UK-based Optellum has developed an AI-powered clinical decision support – called Virtual Nodule Clinic – …

J&J lung cancer initiative will use Optellum’s ‘digital biomarker’ tech Read More »

Novartis’ bid to extend Kymriah into earlier use hits a roadblock

Novartis’ CAR-T therapy Kymriah racked up back-to-back approvals in acute lymphoblastic leukaemia and large B-cell lymphoma a few years ago, but hasn’t added to its label since. Now, a bid to move it onto earlier-stage use in lymphoma has ended in failure. In the phase 3 BELINDA trial, Kymriah (tisagenlecleucel) was unable to extend event-free …

Novartis’ bid to extend Kymriah into earlier use hits a roadblock Read More »

Third strike for GSK/Merck as bintrafusp alfa flubs again

GlaxoSmithKline’s big gamble on Merck KGaA’s bintrafusp alfa has gone from bad to worse, after the drug failed yet another mid-stage trial. The latest disappointment has come from the phase 2 INTR@PID BTC 055 study of the drug alongside chemotherapy as a first-line treatment for patients with locally advanced or metastatic biliary tract cancer (BTC), …

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Pfizer vaults into CD47 arena, buying Trillium for $2.3 billion

Pfizer is the latest big pharma company to take a position on drugs that target CD47 – a ‘don’t eat me’ signal that protects cancer cells from being attacked by the immune system. The drugmaker has agreed a $2.3 billion deal to buy Canadian biotech Trillium Therapeutics and its two lead candidates – TTI-622 and …

Pfizer vaults into CD47 arena, buying Trillium for $2.3 billion Read More »

BMS gets FDA nod for Opdivo as first adjuvant bladder cancer therapy

Bristol-Myers Squibb has scored a win in its drive to get Opdivo into earlier lines of cancer therapy, getting FDA approval for the drug for post-surgical treatment of invasive bladder cancer. The new adjuvant use for Opdivo (nivolumab) is for patients with urothelial carcinoma (UC) – the most common form of bladder cancer – who …

BMS gets FDA nod for Opdivo as first adjuvant bladder cancer therapy Read More »

FDA issues warning on robot-assisted breast cancer surgery

The FDA has issued a safety alert about the use of robot-assisted surgical (RAS) devices for use in mastectomy procedures, pointing out that their safety and efficacy have not been established. The move comes amid reports that some people are being offered RAS for the prevention or treatment of breast cancer, sometimes as part of …

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GSK claims broader ’tissue-agnostic’ label for PD-1 drug Jemperli

The FDA has approved GlaxoSmithKline’s latecomer PD-1 inhibitor Jemperli for a second use that will significantly extend the patient population eligible for treatment with the drug. Jemperli (dostarlimab) can now be used to treat adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours – regardless of where they are located in the body – …

GSK claims broader ’tissue-agnostic’ label for PD-1 drug Jemperli Read More »

Exelixis Expands its Collaboration with Invenra to Develop Novel Biologics in Oncology

Shots: Invenra to receive $15.0M up front along with additional fees and funding to elect up to 20 additional targets in oncology & is eligible for development, regulatory, and commercial milestones along with royalties on net sales of any approved products Exelixis will own all Ab sequences discovered from the collaboration for uses in oncology …

Exelixis Expands its Collaboration with Invenra to Develop Novel Biologics in Oncology Read More »

Merck’s Welireg becomes first drug for rare VHL tumours in US

Merck & Co has extended its range of cancer medicines in the US after claiming FDA approval for Welireg – a drug it acquired as part of its $2.2 billion takeover of Peloton Therapeutics in 2019 – for a family of rare tumours. The drug is part of Merck’s efforts to expand its oncology portfolio …

Merck’s Welireg becomes first drug for rare VHL tumours in US Read More »

NICE changes stance on Lilly’s breast cancer dug Verzenio

After rejecting Eli Lilly’s Verzenio for breast cancer therapy earlier this year, NICE has relented, recommending the drug for routine NHS use alongside hormonal therapy fulvestrant. A final appraisal document from the health technology assessment (HTA) agency backs the use of Verzenio (abemaciclib) alongside fulvestrant for the treatment of women with hormone receptor-positive, HER2-negative breast …

NICE changes stance on Lilly’s breast cancer dug Verzenio Read More »

FDA starts speedy review of Keytruda for adjuvant kidney cancer

Merck & Co is looking at a decision from the FDA in December on its application to market Keytruda as a post-surgery treatment for people with kidney cancer, after a priority review. The drugmaker – known as MSD outside the US and Canada – is seeking approval of Keytruda (pembrolizumab) as an adjuvant treatment for …

FDA starts speedy review of Keytruda for adjuvant kidney cancer Read More »

Collaborate to simplify cancer trials and accelerate post-pandemic recovery

How could simplifying the administration of clinical trials help cancer diagnosis, care, and treatment levels to exceed pre-pandemic levels? Amanda Barrell reports from the ABPI Scotland cancer roundtable discussion. Work to get Scotland’s cancer services back to full strength following the pandemic has already begun, and the pharmaceutical industry has pledged to play its part. …

Collaborate to simplify cancer trials and accelerate post-pandemic recovery Read More »

HER2 heats up as Seagen licenses RemeGen ADC for $2.6bn

Seagen is a specialist in antibody-drug conjugates, but has looked to Chinese biotech RemeGen for a HER2-targeting candidate that could challenge rival drugs from AstraZeneca/Daiichi Sankyo and Roche. The US company is paying $200 million upfront for rex-Asian rights to RemeGen’s disitamab vedotin, with another $2.4 billion in possible future payments tied to future successes …

HER2 heats up as Seagen licenses RemeGen ADC for $2.6bn Read More »

Armed with ph3 trial, Roche preps filing for Polivy in first-line DLBCL

Roche has the results it was hoping for in a phase 3 trial of Polivy in newly diagnosed diffuse large B-cell lymphoma (DLBCL) – an indication it thinks could be worth up to $2 billion. The Swiss drugmaker reported top-line results from the POLARIX study this morning, showing that Polivy (polatuzumab vedotin) was able to …

Armed with ph3 trial, Roche preps filing for Polivy in first-line DLBCL Read More »

Sanofi, Regeneron eye Libtayo challenge to Keytruda in first-line lung cancer

Sanofi and Regeneron’s latecomer checkpoint inhibitor Libtayo has largely been protected from heavyweight competition in its first niche markets, but now looks set to for a toe-to-toe contest with Merck & Co’s class leader Keytruda in the big non-small cell lung cancer (NSCLC) category. Keytruda (pembrolizumab) dominates first-line NSCLC treatment, where it is approved both …

Sanofi, Regeneron eye Libtayo challenge to Keytruda in first-line lung cancer Read More »

Kite takes the ‘Appian way’ to off-the-shelf cell therapies for cancer

Gilead Sciences’ Kite Pharma has mapped out another route to the development of allogeneic or ‘off-the-shelf’ cell therapies for cancer, using technology developed by Appia Bio, a US startup focusing on haematopoietic stem cells (HSCs). The partnership will combine Kite’s experience in chimeric antigen receptor (CAR) therapies with Appia’s platform, which involves using HSCs to …

Kite takes the ‘Appian way’ to off-the-shelf cell therapies for cancer Read More »

Bayer bolsters R&D platform with $2bn Vividion takeover

Bayer headlined its second-quarter results this morning by unveiling a deal to buy Vividion Therapeutics, saying it will boost its ability to develop medicines against targets once considered “undruggable.” Bayer is paying $1.5 billion upfront to claim ownership of Vividion‘s drug discovery platform, which uses chemoproteomics to identify new binding sites on proteins and find …

Bayer bolsters R&D platform with $2bn Vividion takeover Read More »

Failed trial nixes another FDA approval, this time for BMS’ Istodax

Bristol-Myers Squibb’s HDAC inhibitor Istodax has been on the US market for a decade as a treatment for peripheral T-cell lymphoma (PTCL), but will now be withdrawn from sale after a failed phase 3 trial. Istodax (romidepsin) – originally developed by Celgene – is the latest in a string of cancer drugs originally given accelerated …

Failed trial nixes another FDA approval, this time for BMS’ Istodax Read More »

Roche gets fast FDA review for Tecentriq in adjuvant lung cancer

Roche is preparing for a December verdict form the FDA on adjuvant use of its PD-L1 inhibitor Tecentriq as an adjuvant treatment for some patients with non-small cell lung cancer (NSCLC). The US regulator has just started a priority review of the marketing application for Tecentriq (atezolizumab) – given after surgery and platinum-based chemotherapy – …

Roche gets fast FDA review for Tecentriq in adjuvant lung cancer Read More »

Sanofi swoops on partner Translate, buying the mRNA firm for $3.2bn

Sanofi has been forging ever-closer ties with its mRNA partner Translate Bio since the two started working together in 2018, and has now gone all in, offering $3.2 billion to buy the company outright. The $38-per-share deal – a 56% premium to Translate’s recent share price before an after-hours surge in the stock on rumours …

Sanofi swoops on partner Translate, buying the mRNA firm for $3.2bn Read More »

Servier gets a win for cancer drug Tibsovo, bought in $1.8bn Agios deal

Just three months after completing its $1.8 billion takeover of Agios’ oncology pipeline, Servier has reported positive results for lead drug Tibsovo that could expand the use of the drug in acute myeloid leukaemia. Tibsovo (ivosidenib) was already on the market when Servier made its play for Agios’ assets, having secured US approvals as a …

Servier gets a win for cancer drug Tibsovo, bought in $1.8bn Agios deal Read More »

Cancer research faces uncertain post-COVID landscape

There’s a bright future ahead for cancer research in the UK, but only if the government is able to implement a clear plan for funding and development going forward, says The Institute of Cancer Research, London’s Paul Workman. Cancer research in the UK risks facing a “perfect storm” of stalled work and reduced funding that …

Cancer research faces uncertain post-COVID landscape Read More »

BMS claims first EU okay for adjuvant oesophageal cancer immunotherapy

Bristol-Myers Squibb is in a battle with Merck & Co for position in the upper gastrointestinal cancer immunotherapy market, and has just reinforced its position with an EU approval in the post-surgery (adjuvant) setting. The European Commission has approved Opdivo (nivolumab) as the first-ever adjuvant immunotherapy for patients with oesophageal or gastroesophageal junction (GEJ) cancer, …

BMS claims first EU okay for adjuvant oesophageal cancer immunotherapy Read More »

Surprise pandemic lessons for pharma

Ask people in most western nations to think back to 2019 and consider what they would have said then about the potential impact of a pandemic on their everyday lives and my guess is that the vast majority of us would have had little insight into what would happen. Residents of Southeast Asia who had …

Surprise pandemic lessons for pharma Read More »

Lessons from the first generation of cell and gene oncology trials

Advances in cell and gene science are paving the way for transformative cancer treatments, but there are still many complexities in delivering clinical trials for these therapies. ICON’s Tamie Joeckel and Brandon Fletcher take us through best-practice approaches to CGT studies and discuss what the future could hold for this exciting area. Cell and gene …

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AbbVie, Calico raise their age-related disease alliance funding to $3.5bn

AbbVie and Alphabet spin-out Calico Life Sciences have agreed to fund their seven-year-old partnership seeking treatments for diseases of ageing with another $500 million apiece. The collaboration with Google sister company Calico – formed in 2014 with $1.5 billion in funding and extended in 2018 with another $1 billion top up – has already resulted …

AbbVie, Calico raise their age-related disease alliance funding to $3.5bn Read More »

AbbVie, Calico raise their age-related disease alliance funding to $3.5bn

AbbVie and Alphabet spin-out Calico Life Sciences have agreed to fund their seven-year-old partnership seeking treatments for diseases of ageing with another $500 million apiece. The collaboration with Google sister company Calico – formed in 2014 with $1.5 billion in funding and extended in 2018 with another $1 billion top up – has already resulted …

AbbVie, Calico raise their age-related disease alliance funding to $3.5bn Read More »

After false start, Merck claims Keytruda approval in early breast cancer

Merck & Co’s Keytruda has just picked up its 30th approval from the FDA, and it is a good one – early-stage triple-negative breast cancer (TNBC), a particularly hard-to-treat form of the disease. The FDA has given a green light to the use of Keytruda (pembrolizumab) pre-surgery alongside chemotherapy in the neoadjuvant setting, as well …

After false start, Merck claims Keytruda approval in early breast cancer Read More »

Oncology R&D: the patient insights we’re still missing, and how to catch up

Imagine you are a pharma executive working in oncology R&D. The landscape is rapidly becoming more competitive and overcrowded. You are under pressure to bring solutions now, and for your entire career, you have been taught that things must be done a certain way. Patient engagement is viewed by many as a nice-to-have rather than …

Oncology R&D: the patient insights we’re still missing, and how to catch up Read More »

BMS pulls speedy Opdivo approval for liver cancer in US

Bristol-Myers Squibb has withdrawn its US marketing approval for PD-1 inhibitor Opdivo as a second-line, single-agent treatment for hepatocellular carcinoma, a common form of liver cancer, in people previously treated with Bayer/Onyx’s Nexavar. Opdivo (nivolumab) was awarded an accelerated approval in 2017 for second-line HCC treatment on the strength of mid-stage data, but failed to …

BMS pulls speedy Opdivo approval for liver cancer in US Read More »

Digital tools key to immuno-oncology’s future: report

If ASCO 2021 proves anything, it’s that the explosion in immuno-oncology therapies over the last few years shows no signs of slowing down. As the field becomes more crowded, digital tools may be critical for improving outcomes, says a new whitepaper. The whitepaper, ‘The Role of Digital Health in Immuno-oncology Therapy Development and Adoption’ from …

Digital tools key to immuno-oncology’s future: report Read More »

Pfizer puts up $1bn to buy into Arvinas breast cancer programme

Pfizer has pledged a whopping $11 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ natural protein-denaturing machinery to remove rogue proteins associated with disease. The deal focuses on ARV-471, currently in phase 2 testing for advanced breast cancer patients whose tumours expresses oestrogen receptors …

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NICE changes its mind on rare bile duct cancer drug from Incyte

Incyte’s Pemazyre has become the first targeted therapy available for NHS patients with cholangiocarcinoma or bile duct cancer, after NICE concluded it provided value for money. The green light for Pemazyre (pemigatinib) has been hailed by cholangiocarcinoma charity AMMF, which said it was a “major milestone” in the fight against the “Cinderella” cancer, which for …

NICE changes its mind on rare bile duct cancer drug from Incyte Read More »

Oncology and a year of COVID: lessons for the future

COVID’s impact on cancer care and oncology research has been devastating, but the pandemic has also opened up opportunities to take learnings and create long-lasting change in research, practice and education, says Lucid’s Frances O’Connor. The COVID-19 pandemic might finally be in its latter stages after a year and a half of disruption, but its …

Oncology and a year of COVID: lessons for the future Read More »

Arcus’ CMO Grossman jumps ship to join Gilead’s cancer push

Gilead Sciences just forged even closer ties with its cancer drug partner Arcus Biosciences, enticing the biotech’s chief medical officer Bill Grossman to a new role as its head of oncology clinical research. The two companies entered into a 10-year alliance last year, with Gilead claiming certain rights to Arcus clinical and preclinical immuno-oncology candidates …

Arcus’ CMO Grossman jumps ship to join Gilead’s cancer push Read More »

BioNTech grows in cell therapies, buying Kite’s TCR platform

BioNTech has found a use for some of the windfall cash it has raked in from its COVID-19 vaccine, agreeing a deal to buy Kite Pharma’s entire neoantigen T cell receptor (TCR) platform for solid tumours, and an associated manufacturing plant. There’s no value attached to the deal – even though BioNTech is a publicly …

BioNTech grows in cell therapies, buying Kite’s TCR platform Read More »

How hybrid virtual engagement is accelerating oncology communication

COVID has revolutionised the way pharma engages with healthcare stakeholders – but to be truly successful, digital engagement needs to move away from an overreliance on real-time meetings, say experts from Within3. By making virtual meetings a necessity, COVID has forced pharma to adopt a more flexible, digitally-driven approach to stakeholder interaction – but in …

How hybrid virtual engagement is accelerating oncology communication Read More »

AstraZeneca bags Imfinzi okay in big Chinese lung cancer market

China has approved AstraZeneca’s PD-1/PD-L1 inhibitor Imfinzi to treat small-cell lung cancer (SCLC), an aggressive form of the disease that accounts for around 15% of all lung cancer cases. The green light from the National Medical Products Administration (NMPA) covers the use of Imfinzi (durvalumab) alongside platinum-based chemotherapy in previously untreated patients with extensive-stage SCLC. …

AstraZeneca bags Imfinzi okay in big Chinese lung cancer market Read More »

Enabling healthcare’s digital future

Debiopharm Innovation Fund’s Tanja Dowe on investing in digital health start-ups and supporting them on their rollercoaster rides to improve patient outcomes The weight of expectation hangs heavy over the digital health sector. Even before COVID-19 struck, shattering established societal and healthcare norms, much was expected from start-ups that could combine health and tech. Now, …

Enabling healthcare’s digital future Read More »

NICE second Zytiga rejection ‘shows need for flexible pricing models’

NICE has stuck with its original decision to reject NHS funding for Johnson & Johnson’s Zytiga as a treatment for men with newly diagnosed advanced prostate cancer, drawing criticism from the Institute of Cancer Research (ICR).  The UK cost-effectiveness body first turned down Zytiga (abiraterone acetate) for this use in June 2020, but said four …

NICE second Zytiga rejection ‘shows need for flexible pricing models’ Read More »

What HCPs think about health equity in cancer care

After more than a year of COVID-19 dominating health conversations, HCPs have been engaging in dialogue about continually evident disparities that many are facing in healthcare. CREATION.co’s Mary Kangley explores what HCPs think about health equity in cancer care. The topic rose to significance in the American Society of Clinical Oncology (ASCO) whereby they updated …

What HCPs think about health equity in cancer care Read More »

Digital health developments: a new investment era for start-ups

Healthware Labs’ Kristin Milburn explores how digital health start-ups can harness the huge potential for the sector in a post-COVID world and the paths they need to take to grow their business. Digital health has come a long way in the past decade – and Kristin Milburn says that the sector could now be about …

Digital health developments: a new investment era for start-ups Read More »

Why pharma shouldn’t forget about sites in a post-COVID world

The pandemic forced massive changes to oncology sites to ensure patient safety and research continuity – but we must recalibrate and work with sites to understand the value proposition of the technologies and methodologies adopted, says Syneos Health’s Angela Hirst. Formerly an oncology nurse and now director of Sites and Patient Services at Syneos Health’s …

Why pharma shouldn’t forget about sites in a post-COVID world Read More »

GSK cancer head Hoos exits, takes top role at biotech Scorpion

GlaxoSmithKline’s head of oncology Axel Hoos has resigned from the company, and will take up a new role as chief executive of US biotech Scorpion Therapeutics.  Hoos is leaving GSK after nine years, a period that saw a complete revamp of the unit including the wholesale divestment of cancer drugs to Novartis in a $16 …

GSK cancer head Hoos exits, takes top role at biotech Scorpion Read More »

Imugene HER2 vaccine hits target in stomach cancer trial

A peptide vaccine developed by Australia’s Imugene has reduced tumour size in around half of patients with HER2-positive gastric or gastroesophageal junction (GEJ) cancer in a phase 2 trial. The interim readout from the 39-patient HERIZON trial found 50% of patients treated with the HER-Vaxx (IMU-131) vaccine on top of chemotherapy achieved a partial response …

Imugene HER2 vaccine hits target in stomach cancer trial Read More »

When biotech meets reality TV – Starton Therapeutics faces the Unicorn Hunters

Starton Therapeutics is bypassing the traditional venture capital route to raise money for its transdermal delivery technology that delivers medicine through the skin. pharmaphorum hears why the company decided to appear on a new reality investment show. A big clock times a 60 second countdown as biotech CEO Pedro Lichtinger delivers an elevator pitch to …

When biotech meets reality TV – Starton Therapeutics faces the Unicorn Hunters Read More »

Health Innovators: Eliot Forster, F-Star

In this episode of Health Innovators, pharmaphorum founder Paul Tunnah interviews Eliot Forster, CEO of F-Star – a clinical-stage, NASDAQ-listed biopharmaceutical company focused on transforming the lives of patients with cancer.     About the author Dr Paul Tunnah is chief content officer and UK managing director for Healthware Group, a next-generation integrated consulting group that …

Health Innovators: Eliot Forster, F-Star Read More »

Merck pulls Keytruda’s FDA nod for third-line stomach cancer

Merck & Co will voluntarily withdraw a US marketing approval for cancer immunotherapy blockbuster Keytruda in gastric cancer, after studies intended to confirm its efficacy in this setting were a bust.  The decision comes after FDA advisors voted six to two in April that Keytruda (pembrolizumab) should not stay on the market as a treatment …

Merck pulls Keytruda’s FDA nod for third-line stomach cancer Read More »

BMS pays $650m upfront for Eisai’s first ADC candidate for cancer

Japan’s Eisai has hit the jackpot with its first ever antibody-drug conjugate (ADC) drug candidate, attracting a licensing deal from Bristol-Myers Squibb that could top out at more than $3.1 billion.  BMS is making a hefty $650 million upfront payment to Eisai for global co-development and co-commercialisation rights to MORAb-202, which couples an anti-folate receptor …

BMS pays $650m upfront for Eisai’s first ADC candidate for cancer Read More »

Gilead combs Shoreline for NK cell therapies in $2.3bn alliance

Gilead Sciences’ cell therapy Kite Pharma has bulked up its position in natural killer (NK) cell therapies, pledging up to $2.3 billion for a partnership with Shoreline Bioscience focusing on off-the-shelf therapies for haematological cancers. The two companies will collaborate on the development of targeted NK cell and macrophage cells derived from induced pluripotent stem …

Gilead combs Shoreline for NK cell therapies in $2.3bn alliance Read More »

Blueprint’s latest approval for Ayvakit sets up clash with Novartis

Blueprint Medicines has claimed its second FDA approval for Ayvakit, getting the nod for advanced systemic mastocytosis (SM), a group of rare blood cancers currently treated mainly by Novartis’ Rydapt.  The FDA has cleared Ayvakit (avapritinib) for adults with SM, including the three major subtypes – aggressive disease with or without an associated haematological neoplasm, …

Blueprint’s latest approval for Ayvakit sets up clash with Novartis Read More »

Ambrx tries another IPO as it chases down HER2 rivals

California biotech Ambrx Biopharma is hoping to raise $126 million from a listing on the New York Stock Exchange (NYSE) that will be used in part to fund clinical development of ARX-788, its HER2-targeting antibody drug conjugate (ADC). The Scripps Research spinout could be just 18 months away from licensee NovoCodex reporting results of a …

Ambrx tries another IPO as it chases down HER2 rivals Read More »

Exscientia buys Allcyte to add patient sample testing to its AI platform

UK-based artificial intelligence pioneer Exscientia has made a play to stay at the forefront of the field, acquiring Austrian rival Allcyte with the help of its recent $525 million financing. The €50 million ($61 million) deal – in cash and stock – will give Exscientia ownership of a technology platform that takes patient samples and …

Exscientia buys Allcyte to add patient sample testing to its AI platform Read More »

GSK joins ant-TIGIT push with $625m upfront iTeos deal

GlaxoSmithKline has staked a claim to the fast-moving category of cancer therapies targeting the TIGIT immune checkpoint, agreeing a $2 billion plus licensing agreement with iTeos Therapeutics for an antibody candidate in early clinical development. The deal includes $625 million in upfront fees to secure rights to EOS-448, which is currently in a phase 1 …

GSK joins ant-TIGIT push with $625m upfront iTeos deal Read More »

Daiichi Sankyo claims first okay for oncolytic virus in Japan

Daiichi Sankyo has made a little bit of pharma industry history, becoming the first drugmaker to win approval in Japan for a therapy for cancer based on a virus that selectively kills malignant cells. Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted a conditional approval to the company’s Delytact (teserpaturev) for the treatment …

Daiichi Sankyo claims first okay for oncolytic virus in Japan Read More »

BMS will file for earlier-line use of Breyanzi in lymphoma after trial win

Bristol-Myer Squibb has only just won FDA approval for its CAR-T Breyanzi in large B-cell lymphoma (LBCL), but is already eyeing an expansion into earlier-line therapy that could overtake rival therapies from Novartis and Gilead Sciences. Breyanzi (lisocabtagene maraleucel or liso-cel) was approved in February for use in LBCL patients after two prior systemic therapies, …

BMS will file for earlier-line use of Breyanzi in lymphoma after trial win Read More »

Country focus: China & APAC’s growing medical needs bring opportunities and challenges

Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. Home to over 60% of the world’s population, Asia Pacific (APAC) is not a region the biopharma industry can afford to ignore. Dr Jay Mei, founder and …

Country focus: China & APAC’s growing medical needs bring opportunities and challenges Read More »

Scotland backs rare blood cancer drug Poteligeo rejected by NICE

A north-south divide has emerged in UK medicines access after the Scottish Medicines Consortium (SMC) okayed Kyowa Kirin’s Poteligeo for two rare blood cancers, a few weeks after the drug was turned in England by NICE. Poteligeo (mogamulizumab) has been backed by the SMC for adults living with mycosis fungoides (MF) and Sézary syndrome (SS), …

Scotland backs rare blood cancer drug Poteligeo rejected by NICE Read More »

J&J backs out of $1.6bn blood cancer antibody alliance with Argenx

Belgian biotech Argenx has lost its development partner for acute myeloid leukaemia antibody cusatuzumab, after Johnson & Johnson backed away from the alliance after two and a half years. J&J’s Cilag unit – part of its Janssen pharma division – said this morning that it had decided not to continue the collaboration after a “review …

J&J backs out of $1.6bn blood cancer antibody alliance with Argenx Read More »

ASCO21: AZ seeks to supplant Imbruvica in CLL with new Calquence data

AstraZeneca has thrown down the gauntlet to AbbVie and Johnson & Johnson with new data for Calquence in chronic lymphocytic leukaemia (CLL) that it says show a safety advantage over Imbruvica – currently dominating the BTK inhibitor market. In the ELEVATE-RR study, Calquence (acalabrutinib) matched Imbruvica (ibrutinib) when it came to keeping adults with previously …

ASCO21: AZ seeks to supplant Imbruvica in CLL with new Calquence data Read More »

ASCO21: Gilead sets up first FDA okay for adult ALL with Tecartus data

Novartis’ Kymriah has had the CAR-T therapy market for acute lymphoblastic leukaemia (ALL) to itself so far, but Gilead Sciences’ Kite subsidiary is now looming in the rear view mirror – armed with new data for its already-filed rival Tecartus. Results of the phase 1/2 ZUMA-3 trial of Tecartus (brexucabtagene autoleucel) reported at the ongoing …

ASCO21: Gilead sets up first FDA okay for adult ALL with Tecartus data Read More »

Prostate Cancer Drug Development Summit

The inaugural Prostate Cancer Drug Development Summit is the only industry-led meeting uniting large pharma, biotech and pioneering academics with the ambitious objective of accelerating the clinical development of safe and effective therapies to treat prostate cancer. With sessions on both early and advanced stages of prostate cancer (Non-Metastatic Castrate-Resistant Prostate Cancer (nmCRPC) and Metastatic Castrate-Resistant Prostate Cancer (mCRPC), this is a conversation not …

Prostate Cancer Drug Development Summit Read More »

ASCO21: Lynparza aces adjuvant breast cancer therapy trial

AstraZeneca and Merck & Co’s Lynparza is primed for even wider use in the treatment of breast cancer after a phase 3 trial showed it could extend the time for the cancer to return when used as adjuvant therapy. Giving Lynparza (olaparib) to women with BRCA-positive, HER2-negative breast cancer straight after chemotherapy and surgery to …

ASCO21: Lynparza aces adjuvant breast cancer therapy trial Read More »

Bayer props up sagging radionuclide business with Noria acquisition

Bayer has agreed to buy Noria Therapeutics and its subsidiary PSMA Therapeutics, adding to its pipeline of radionuclide drugs for cancer as sales of its lead product in the category – Xofigo – continue to decline.  Just over three years ago, Bayer was forced to concede that its blockbuster expectations for Xofigo (radium Ra 223 …

Bayer props up sagging radionuclide business with Noria acquisition Read More »

ASCO21: Novartis’ prostate cancer radiotherapy extends survival

Novartis’ big investment in radiopharmaceuticals for cancer seems to have paid off, after lead candidate 177Lu-PSMA-617 helped men with advanced prostate cancer and few treatment options live longer in a phase 3 trial. New data from the VISION study showed that 177Lu-PSMA-617 on top of standard care reduced the risk of death by 38% compared …

ASCO21: Novartis’ prostate cancer radiotherapy extends survival Read More »

Changing focus to cachexia may be key to improved cancer outcomes

Cachexia could be the next blockbuster area in cancer therapeutics because of its link to survival outcomes. Physician and researcher Dr. Daniel L Marks discusses the historial challenges to developing a therapeutic for this condition and what may finally be on the horizon.  Until recently, cancer research and resulting therapeutic approaches have focused on one …

Changing focus to cachexia may be key to improved cancer outcomes Read More »

Genmab takes aims at immuno-oncology antibody conjugates with Bolt Bio

Genmab has enlisted the help of Bolt Biotherapeutics to develop a new class of immune-boosting antibody conjugates for cancer in a deal that could be worth up to $880 million. Denmark-based Genmab is paying $10 million upfront to its US counterpart and making a $15 million equity investment to get the project started, funding R&D …

Genmab takes aims at immuno-oncology antibody conjugates with Bolt Bio Read More »

PAVmed Launches Veris Health With Acquisition of Oncodisc –M&A

What You Should Know: – PAVmed announced today their launch of digital health company, Veris Health, along with Veris’ acquisition of Oncodisc.  – Oncodisc was created by James Mitchell, M.D. and Andrew Thoreson, M.D.  and brings the first implantable vascular access port with biologic sensors and wireless communication, combined with an oncologist-designed remote digital healthcare platform to improve …

PAVmed Launches Veris Health With Acquisition of Oncodisc –M&A Read More »

MorphoSys offers $1.7bn for Constellation, but investors see stars

Shares in German biotech MorphoSys have gone on the slide after it announced a $1.7 billion deal to buy its US rival Constellation Pharma and its pipeline of cancer and haematology therapies. MorphoSys said the $34 per share deal would accelerate growth by adding two clinical-stage drug candidates, namely BET inhibitor pelabresib (CPI-0610) in phase …

MorphoSys offers $1.7bn for Constellation, but investors see stars Read More »

Amgen nabs speedy approval for first-ever KRAS drug sotorasib

After decades of mostly unsuccessful R&D, Amgen has claimed the first ever regulatory approval for a drug that inhibits KRAS – a cancer target that for a long time was all-but written off as “undruggable”. The FDA’s conditional approval for Lumakras (sotorasib; formerly AMG-510) as a second-line treatment for KRAS G12c-mutated non-small cell lung cancer …

Amgen nabs speedy approval for first-ever KRAS drug sotorasib Read More »

FDA sets November review date for J&J’s multiple myeloma CAR-T cilta-cel

Johnson & Johnson has secured a six-month FDA review for its multiple myeloma CAR-T therapy ciltacabtagene autoleucel (cilta-cel), narrowing the lead for Bristol-Myers Squibb and bluebird bio’s rival Abecma. The US regulator is now scheduled to complete its review of cilta-cel by 29 November for adults with relapsed and/or refractory multiple myeloma who have previously …

FDA sets November review date for J&J’s multiple myeloma CAR-T cilta-cel Read More »

New Cell & Gene Therapy Collective seeks to boost UK adoption

The UK has been a global leader in introducing cell and gene therapies that can potentially transform the lives of patients with debilitating diseases – but there are still many barriers to wider adoption. These challenges often arise because these therapies go through the same value assessment processes as less complex medicines, and the infrastructure …

New Cell & Gene Therapy Collective seeks to boost UK adoption Read More »

Straight after its first cancer bispecific OK, J&J highlights two more at ASCO

With the ink barely dry on the FDA’s approval of Johnson & Johnson’s Rybrevant, its first bispecific antibody for cancer, the drugmaker is already showcasing others in its pipeline.  Two of its earlier-stage bispecifics – both in development for the blood cancer multiple myeloma – will feature at the American Society of Clinical Oncology (ASCO) …

Straight after its first cancer bispecific OK, J&J highlights two more at ASCO Read More »

Janssen claims FDA okay for would-be Tagrisso rival Rybrevant

Johnson & Johnson’s Janssen division has claimed a first approval in the US for its bispecific antibody Rybrevant as a treatment for EGFR-mutated non-small cell lung cancer (NSCLC). Rybrevant (amivantamab) – originally developed by Danish biotech Genmab – has been cleared for NSCLC patients with exon 20 insertions, the third most common EGFR mutation in …

Janssen claims FDA okay for would-be Tagrisso rival Rybrevant Read More »

ChristianaCare added a primary care practice to its cancer center. Here’s why.

When ChristianaCare’s Graham Cancer Center saw that a significant number of its patients did not have a primary care provider, they decided to take action. Now, any patient that doesn’t already have a PCP is connected to one onsite at the cancer center, expanding the care each patient receives.

Allogene set to disrupt CAR-T market with pivotal trial of ‘off the shelf’ therapy

In 2018, the former leadership of team from Kite Pharma founded Allogene, on a mission to outdo the CAR-T cancer cell therapies they had just sold to Gilead for $12 billion with an “off-the-shelf” rival that could be cheaper and easier to use. Data announced ahead of this year’s American Society of Clinical Oncology (ASCO) …

Allogene set to disrupt CAR-T market with pivotal trial of ‘off the shelf’ therapy Read More »

Vinehealth earns CE marks for cancer management apps

UK digital health firm Vinehealth has won a CE mark for a mobile app that helps cancer patients manage their medications and care, as well as a sister web-based app aimed at clinicians.  The Vinehealth Cancer Companion – originally developed by neurologist Dr Rayna Patel and Georgina Kirby, the company’s co-founders – uses behavioural science …

Vinehealth earns CE marks for cancer management apps Read More »

LAG-3 drugs take centre stage at ASCO, showing potential as next-gen immunotherapies

LAG-3 drugs from arch-rivals Bristol-Myers Squibb and Merck & Co look set to become talking points at this year’s ASCO conference after trial results showed their potential as next-generation cancer immunotherapies. Bristol-Myers Squibb made a splash ahead of the virtual conference early next month, with results showing a single infusion of its LAG-3 blocker relatlimab …

LAG-3 drugs take centre stage at ASCO, showing potential as next-gen immunotherapies Read More »

Numab raises $110m to develop cancer bispecific antibodies

Switzerland’s Numab has raised 100 million Swiss francs – around $110 million – in Series C financing to develop bispecific antibodies for cancer and inflammation, with Novo Noldings and HBM Partners co-leading the investor syndicate. Proceeds will support acceleration and expansion of the clinical development of Numab’s lead drug NM21-1480 into several cancer indications. It …

Numab raises $110m to develop cancer bispecific antibodies Read More »

BMS Extends its 2019 Collaboration with Exscientia for AI Driven Drug Discovery

Shots: Exscientia to receive ~$50M as up front, ~$125M as milestones and additional clinical, regulatory, and commercial milestones of over $1.2B along with royalties on net sales of any marketed therapies resulting from the collaboration The expanded collaboration has the potential to add to the BMS drug pipeline whilst enhancing Exscientia’s portfolio of shared assets. …

BMS Extends its 2019 Collaboration with Exscientia for AI Driven Drug Discovery Read More »

FDA review of Lilly/Innovent’s sintilimab paves way for cut-price immunotherapy option

The FDA has accepted Eli Lilly and China’s Innovent filing for their latecomer immunotherapy sintilimab, which is expected to compete on price with rivals such as Merck & Co’s Keytruda. The companies filed for approval for the PD-1 inhibitor in untreated nonsquamous non-small lung cancer in combination with pemetrexed and platinum chemotherapy. It’s the first …

FDA review of Lilly/Innovent’s sintilimab paves way for cut-price immunotherapy option Read More »

BMS agrees deal worth up to $1.56bn for Agenus’ TIGIT cancer drug

Bristol-Myers Squibb has paid $200 million, and promised up to $1.36 billion in “biobucks” for exclusive rights to a cancer antibody still in the labs of US biotech Agenus, which blocks the TIGIT receptor that is emerging as an immunotherapy target. Roche is one of the leaders in research in to TIGIT – short for …

BMS agrees deal worth up to $1.56bn for Agenus’ TIGIT cancer drug Read More »

AZ/Daiichi unveil data from TNBC hopeful datopotamab deruxtecan

AstraZeneca and Daiichi Sankyo have revealed new data from datopotamab deruxtecan in triple negative breast cancer (TNBC) – and although it’s from a small patient group results look impressive. To recap, AZ shelled out $1bn for rights to datopotamab last year, an antibody-drug conjugate (ADC) consisting of an antibody that targets tumours and a lethal …

AZ/Daiichi unveil data from TNBC hopeful datopotamab deruxtecan Read More »

Patients in England get fast access to AZ’s Tagrisso in early lung cancer

The UK’s drugs regulator has swiftly granted a licence extension for AstraZeneca’s Tagrisso in certain patients with early stage lung cancer, with NICE allowing fast access to patients on England’s NHS. The arrangements under Project Orbis, a global project run by the FDA that the Medicines and Healthcare products Regulatory Authority is supporting, aim to …

Patients in England get fast access to AZ’s Tagrisso in early lung cancer Read More »

NICE says no to Merck Serono’s Bavencio in bladder cancer

Merck Serono’s Bavencio is the only checkpoint inhibitor to be approved for first-line maintenance treatment of bladder cancer in Europe, but UK cost-effectiveness agency NICE says it is too expensive to justify routine NHS use.  Bavencio (avelumab) was approved in the UK earlier this year for locally advanced or metastatic urothelial carcinoma (UC) – the …

NICE says no to Merck Serono’s Bavencio in bladder cancer Read More »

Roche’s Tecentriq gets fourth European lung cancer indication

Roche’s cancer immunotherapy Tecentriq has been granted a new use by European regulators, for the first-line treatment of certain patients with metastatic non-small cell lung cancer (NSCLC). Tecentriq (atezolizumab) has now been used in Europe for adults with metastatic NSCLC whose tumours have high PD-L1 expression. The tumours must also have no epidermal growth factor …

Roche’s Tecentriq gets fourth European lung cancer indication Read More »

Janssen files its first CAR-T therapy cilta-cel in Europe

Johnson & Johnson’s Janssen unit has filed for approval of its multiple myeloma CAR-T ciltacabtagene autoleucel in Europe, chasing after a rival therapy from Bristol-Myers Squibb.  The BCMA-targeting CAR-T – also known as cilta-cel – has been filed with the EMA as a treatment for adults with relapsed/refractory multiple myeloma, an incurable form of blood …

Janssen files its first CAR-T therapy cilta-cel in Europe Read More »

Keytruda should lose stomach cancer indication, says ODAC

The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to strip Merck & Co’s Keytruda of its accelerated approval in gastric and gastroesophageal junction (GEJ) cancer, despite a lack of treatment options in these patients.  The panel voted 6 to 2 that Keytruda (pembrolizumab) should not stay on the market for PD-L1–positive gastric or GEJ …

Keytruda should lose stomach cancer indication, says ODAC Read More »

ODAC votes to keep bladder cancer labels for Keytruda, Tecentriq

Merck & Co’s Keytruda and Roche’s Tecentriq should stay on the market as first-line treatments for bladder cancer, at least until new clinical data becomes available next year.  That was the conclusion at the second day of a meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC), convened to discuss three immuno-oncology drugs granted conditional …

ODAC votes to keep bladder cancer labels for Keytruda, Tecentriq Read More »

Tecentriq can stay as therapy for triple-negative breast cancer, FDA experts say

Roche’s Tecentriq can stay on the US market as a therapy for triple negative breast cancer, advisers to the FDA have said as part of a review of several quickly-approved cancer drugs. Tecentriq was the first drug to be discussed in the review by the FDA’s Oncologic Drugs Advisory Committee (ODAC) of cancer drugs that …

Tecentriq can stay as therapy for triple-negative breast cancer, FDA experts say Read More »

FDA looks at pulling speedy approvals for three cancer drugs

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market.  The Oncologic Drugs Advisory Committee (ODAC) is scheduled to look at the data for the three drugs – Merck & Co’s Keytruda (pembrolizumab), Bristol-Myers Squibb’s Opdivo (nivolumab) and Roche’s Tecentriq …

FDA looks at pulling speedy approvals for three cancer drugs Read More »

Proton Therapy – Ultimate Guide for Patients

Proton therapy is expected to be the next big thing in future of medical science. The advanced mode of treatment deserves all the hype it garners as it is the result of intense research and thorough study of innumerable researchers and doctors all across the globe. The concept of proton therapy was proposed by Robert …

Proton Therapy – Ultimate Guide for Patients Read More »

Enhertu cleared for NHS use via Cancer Drugs Fund

NICE has recommended the use of AstraZeneca and Daiichi Sankyo’s Enhertu in draft guidance, the first time the drug has been commissioned in any European country.  The UK health technology assessment (HTA) agency has backed Enhertu (trastuzumab deruxtecan) as a therapy for HER2 positive breast cancer which can’t be surgically removed or which has spread …

Enhertu cleared for NHS use via Cancer Drugs Fund Read More »

J&J decides against Erleada+Zytiga combination prostate cancer filing

Johnson & Johnson won’t be filing a prostate cancer therapy combining its Erleada and Zytiga drugs with regulators, after a phase 3 trial showed it didn’t improve survival compared with Zytiga alone. Zytiga is the older of the two drugs and was used in the active control arm of the ACIS study, which tested the …

J&J decides against Erleada+Zytiga combination prostate cancer filing Read More »

Astellas, Seagen seek speedy reviews of Padcev in bladder cancer

The next milestone in Seagen and Astellas’ bid to build their antibody-drug conjugate (ADC) Padcev into a blockbuster will come in August, when the FDA concludes an accelerated review of two bladder cancer filings.  One of the filings is to convert the ADC’s current conditional approval as a later-line therapy for urothelial cancer in patients …

Astellas, Seagen seek speedy reviews of Padcev in bladder cancer Read More »

Non-Small Cell Lung Cancer Drug Development Summit

The Non-Small Cell Lung Cancer (NSCLC) Drug Development Summit is the definitive industry-led forum for drug development in the largest solid tumor indication. This is a strategic conference designed to bring drug development teams together to address critical challenges surrounding therapeutic potency, tumor resistance and relapse and expanding the clinical utility of targeted and immuno-therapies, either in combination or …

Non-Small Cell Lung Cancer Drug Development Summit Read More »

Komodo Health Launches Next-Gen AI to Accelerate Innovation and Close Gaps in Care

What You Should Know: – Today, Komodo Health is capping off a month-long flurry of activity by announcing the launch of its Prism and Sentinel solutions — opening up access to its Healthcare Map to drive the next generation of AI innovation.  – Prism and Sentinel allows life sciences teams to tap into detailed patient behaviors and treatment patterns …

Komodo Health Launches Next-Gen AI to Accelerate Innovation and Close Gaps in Care Read More »

Boehringer and MD Anderson extend KRAS cancer collaboration

Boehringer Ingelheim and The University of Texas MD Anderson Cancer Center have extended and expanded a collaboration exploring medicines targeting lung cancer with KRAS mutations.  The collaboration was launched in 2019 and in its next phase will explore new molecules from Boehringer’s KRAS (Kirsten rat sarcoma) and TRAILR2 (TNF-related apoptosis-inducing ligand receptor 2) portfolios, with a …

Boehringer and MD Anderson extend KRAS cancer collaboration Read More »

Gilead’s Trodelvy approved in metastatic urothelial cancer

Gilead’s Trodelvy has another string to its bow after FDA approval in patients with advanced metastatic urothelial cancer.  Trodelvy (sacituzumab govitecan) has been approved for locally advanced or metastatic urothelial cancer, following a platinum-containing chemotherapy and PD-1/PD-L1 inhibitor immunotherapy. The US pharma hopes that the drug will be used in those patients who have not …

Gilead’s Trodelvy approved in metastatic urothelial cancer Read More »

AZ aims at Pfizer, GSK with potential new PARP cancer drug

AstraZeneca’s Lynparza (olaparib) blazed a trail for the new class of PARP drugs when it was approved in 2014 to treat ovarian cancer.  The drug has gone on to become a huge success, generating sales of nearly $1.8 billion in 2020 alone as part of a partnership with Merck & Co after expanded use in …

AZ aims at Pfizer, GSK with potential new PARP cancer drug Read More »

PHINs: Addressing the Fundamental Flaws that Have Broken Healthcare

 Brad Bostic, CEO, hc1 The fundamental problem with healthcare can be summed up in one sentence:  We expect healthcare services that cater to our individual needs, yet the health care system operates under a one-size-fits-all, trial-and-error model. It is a model that results in missed diagnoses, protracted illnesses, and even premature death and wastes $935 …

PHINs: Addressing the Fundamental Flaws that Have Broken Healthcare Read More »

STING & TLR Targeting Therapies Summit

This is the definitive drug development forum for research teams to investigate how to modulate the cGAS-STING and Toll-like receptor (7/8/9) pathways both as monotherapies and as adjuvants in combinatorial approaches. This meeting comes at a critical point for the cancer immunotherapy field, as researchers look to increase patient response rates and the efficacy on checkpoint inhibitors in several …

STING & TLR Targeting Therapies Summit Read More »

Exscientia starts trials of first AI-derived cancer immunotherapy

Exscientia was the first company to start human trials of a new drug designed using artificial intelligence (AI) last year, and now says it has started testing of the first AI candidate for immuno-oncology.  Oxford, UK-based Exscientia has been working with German biotech Evotec on the adenosine A2a receptor antagonist, which is being tested as …

Exscientia starts trials of first AI-derived cancer immunotherapy Read More »

The next generation of immunotherapy? Innate Pharma targets NK cells

Clinical-stage oncology biotech Innate Pharma is on a mission to harness the power of natural killer cells to fight cancer. Catherine Longworth spoke to CEO Mondher Mahjoubi to find out the science behind this next generation of immunotherapies.  Founded in 1999, Marseille-based company Innate Pharma is on a mission to develop immunotherapies that take advantage …

The next generation of immunotherapy? Innate Pharma targets NK cells Read More »

Merck’s Keytruda demonstrates adjuvant use in kidney cancer

Merck & Co has announced interim data from its pivotal Phase 3 KEYNOTE-564 trial evaluating immunotherapy Keytruda for the potential adjuvant treatment of patients with renal cell carcinoma (RCC) following surgery.  The interim analysis carried out by an independent data monitoring committee, revealed Keytruda showed a statistically significant and clinically meaningfully improvement in disease free …

Merck’s Keytruda demonstrates adjuvant use in kidney cancer Read More »

Cancer Research UK spinout Achilles raises $175.5m in IPO

UK biotech Achilles Therapeutics has completed its initial public offering (IPO) in the US, raising $175.5 million that will be used to take its personalised T cell therapy for lung and skin cancers through proof-of-concept trials. The new funding will also be used to advance two more T cell programmes for head and neck and …

Cancer Research UK spinout Achilles raises $175.5m in IPO Read More »

Gilead scores US approval for breast cancer drug that wowed ESMO

Gilead’s $21 billion purchase of Immunomedics and its potential blockbuster Trodelvy continues to pay off, as the drug has now been approved by the FDA for triple-negative breast cancer.  Trodelvy (sacituzumab govitecan) was granted accelerated approval by the FDA in April last year, and is now indicated for adults with triple-negative breast cancer who have …

Gilead scores US approval for breast cancer drug that wowed ESMO Read More »

Cardinal Health and Deep Lens Collaborate for AI-based Oncology Clinical Trial Matching

What You Should Know: – Today, Deep Lens and Cardinal Health announced a strategic collaboration that will integrate Deep Lens’ AI-based clinical trial matching solution, VIPER, into community-based oncology practices throughout the Cardinal network. VIPER will be a part of Cardinal Health’s new Navista advanced suite of technology solutions designed to help oncologists improve outcomes, …

Cardinal Health and Deep Lens Collaborate for AI-based Oncology Clinical Trial Matching Read More »

Novartis expands in radio-oncology again with $1.3bn Artios alliance

In its second licensing deal in the radio-oncology area in consecutive weeks, Novartis has agreed a $1.3 billion-plus alliance with UK biotech Artios Pharma to develop precision medicines for cancer. The collaboration will focus on combining Artios’ DNA damage response (DDR) drug candidates with Novartis’ radioligand therapies, which consist of tumour-targeting molecules carrying radioactive isotopes …

Novartis expands in radio-oncology again with $1.3bn Artios alliance Read More »

Measuring the Value Healthy Individuals Place on Generous Insurance Coverage of Severe Diseases

That is the title of a paper I just published at Value in Health with Suepattra G. May, Lauren M. Zhao, Katalin Bognar, Yong Yuan, John R. Penrod, and John A. Romley. The subtitle is A Stated Preference Survey of Adults Diagnosed With and Without Lung Cancer. The full abstract is below: Objectives: To compare …

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9th PREDiCT: Tumor Models Cell Therapy Summit

With high stakes to satisfy unmet patient needs, cell therapy is a promising but challenging field of oncology. There is a crucial need to progress candidates from bench to bedside. With that in mind, I am delighted to share the official agenda and speaker faculty for the 9th PREDiCT: Tumor Models Cell Therapy Summit. Taking place as …

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3rd Cell Engager Summit

With that in mind, the 3rd Cell Engager Summit (June 30 – July 1) is the only industry-led meeting focused on developing multi-specific cell engaging therapies in solid tumor indications, and accelerating early discovery innovation into the clinic. With over 32 world-class speakers set to share their ground-breaking insights, this is a learning and networking experience you won’t want to …

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Sanofi’s Sarclisa gains new US multiple myeloma indication

The FDA has approved Sanofi’s Sarclisa (isatuximab) in combination with a new chemotherapy regimen for advanced multiple myeloma, building on a first approval last year. This label extension covers use of Sarclisa plus carfilzomib and dexamethasone for adults with relapsed or refractory multiple myeloma, who have received one to three previous therapy lines. This new …

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Country focus: Hungary carves out a niche in digital pharma

AI simulated cell company Turbine is just one of many digital drug discovery firms on the rise in Hungary. We speak to the company’s CEO and co-founder, Szabolcs Nagy, to find out why moving beyond traditional biotech drug development is a good fit for the country’s ecosystem. Hungarian company, Turbine, is taking an alternative approach …

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Novartis builds radio-oncology pipeline with iTheranostics deal

Novartis has added to its pipeline of radiopharmaceuticals pipeline once again, licensing a series of agents from iTheranostics that can be used to show where tumours are located in the body.  The diagnostic imaging agents all target fibroblast activation protein (FAP), a molecule that is only expressed at low levels on healthy cells but is …

Novartis builds radio-oncology pipeline with iTheranostics deal Read More »

TG Therapeutics completes FDA filing for Roche challenger in CLL

TG Therapeutics has completed its rolling FDA filing for its U2 combination therapy consisting of the antibody ublituximab with the oral drug Ukoniq (umbralisib) as a treatment for chronic lymphocytic leukaemia (CLL). The US pharma is mounting a challenge to Roche, which markets an antibody therapy, Gazyvaro (obinutuzumab) in advanced CLL. Like Gazyvaro, ublituximab targets …

TG Therapeutics completes FDA filing for Roche challenger in CLL Read More »

FDA approves BMS’ multiple myeloma CAR-T Abecma

The FDA has approved Bristol-Myers Squibb’s Abecma (idecabtagene vicleucel) for multiple myeloma, the first cell therapy to treat the disease. Abecma’s review was delayed after the FDA rejected a first filing in May last year, but it’s hoped that the drug could be a significant step forward in the treatment of this incurable condition. It …

FDA approves BMS’ multiple myeloma CAR-T Abecma Read More »

To Advance Health Equity, Put Real-World Cancer Data to Work

Dr. Miller, Medical Director of CancerLinQ LLC Despite decades of scientific progress against cancer, access to treatment remains highly unequal. Some of the reasons — like institutional racism and poverty — are a reflection of our broader society. Other inequities may go unrecognized but are no less damaging. People with underlying health conditions, for example, …

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COSMIC database matches drugs to cancer mutations

The world’s largest database of cancer mutations can now be used to link mutations with drug treatments in what promises to be a step forward in precision oncology.  The COSMIC (Catalogue of Somatic Mutations in Cancer) database, operated by the Wellcome Sanger Institute, grew out of the work of the Cancer Genome Project and has …

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Cancer services should be rebuilt after COVID disruption, experts say

There is a pressing need for a joined-up cancer strategy to reverse the impact of the COVID-19 pandemic, according to a new report from the UK’s pharma industry. The Association of the British Pharmaceutical Industry (ABPI) report said that the UK must be more ambitious with its cancer strategy if it is to compete with …

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NeoGenomics Acquires Precision Oncology Platform Trapelo Health for $65M

What You Should Know: – NeoGenomics, Inc., a provider of cancer-focused genetic testing services and global oncology contract research services announced it has reached an agreement to acquire precision oncology platform Trapelo Health for $65M. The agreement purchase price of $65 million, consists of $35 million in cash on hand and $30 million in NeoGenomics …

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Novartis’ radioligand therapy meets phase 3 prostate cancer trial target

Novartis’ radioligand therapy Lu-PSMA-617 has met its target in prostate cancer, as its $2.1 billion acquisition of specialist pharma Endocyte looks to have been justified.  The big Swiss pharma added this drug to its pipeline after it swooped for Endocyte and so far it looks like a good piece of business, with potential blockbuster sales …

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Aura raises $80m to develop its virus-like cancer drugs

US biotech Aura Biosciences has closed an oversubscribed financing, raising $80 million to help take its lead virus-like drug conjugate (VDC) for a cancer that affects the eye into late-stage development. The Cambridge, Massachusetts-based company is currently testing belzupacap sarotalocan (AU-011) in a phase 2 trial involving patients with choroidal melanoma, a tumour that develops …

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Sanofi, Regeneron prep filings for Libtayo in cervical cancer

Sanofi and Regeneron’s checkpoint inhibitor Libtayo has become the first immunotherapy to improve survival when used as a second-line therapy in cervical cancer, setting up regulatory filings later this year. A phase 3 trial of the PD-1 inhibitor in cervical cancer patients who had progressed after first-line chemotherapy has been stopped early after an interim …

Sanofi, Regeneron prep filings for Libtayo in cervical cancer Read More »