Haematology

ASH abstract drop backs Roche’s Polivy in first-line lymphoma

Roche trumpeted a top-line results of the POLARIX trial of its Polivy therapy in previously-untreated B-cell lymphoma, and a first look at the data suggests it is on track for approval in what could be a highly lucrative new market. An abstract of the results published ahead of the upcoming American Society of Haematology (ASH) …

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Joy as sickle cell patients get access to Novartis’ Adakveo after NICE ruling

People living with sickle cell disease (SCD) in England and Wales will be able to get access to treatment with Novartis’ Adakveo, thanks to a special arrangement between the drugmaker and NICE. The decision makes Adakveo (crizanlizumab) the first new treatment for SCD available via the NHS for 20 years, according to the cost-effectiveness agency, …

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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 …

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After FDA snub, EMA backs FibroGen, Astellas’ roxadustat

The EU regulator has approved  FibroGen and Astellas Evrenzo for adults with anaemia caused by chronic kidney disease (CKD), just days after the FDA turned down the drug in the US. The decision makes Evrenzo (roxadustat) the first oral HIF-PH inhibitor to be cleared for use in the EU, ahead of rival candidates daprodustat from …

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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 …

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EHA21: Novartis trumpets iptacopan as oral alternative to antibodies in PNH

The mainstay of therapy for the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH) is Alexion’s infusion therapy Soliris, but Novartis’ iptacopan could provide an oral option after positive phase 2 trial results. The first-in-class therapy – a targeted factor B inhibitor – was able to “substantially” reduce the destruction of red blood cells (haemolysis) that …

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EHA21: Sanofi builds case for rare disease drug sutimlimab after FDA rejection

Sanofi’s hopes of a speedy approval of first-in-class C1s inhibitor sutimlimab in rare disorder cold agglutinin disease (CAD) were dashed by the FDA, but new phase 3 data keep the drugmaker on track for a resubmission before year-end. The results of the 42-subject CADENZA study – reported at the ongoing European Haematology Association (EHA) – …

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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, …

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Study links AstraZeneca COVID-19 shot to bleeding disorder ITP

Researchers in Scotland have identified a possible link between the Oxford University/AstraZeneca COVID-19 and a mostly mild and generally treatable bleeding disorder. The scientists examined real-world public health data from all individuals in Scotland who received either the AZ or Pfizer/BioNTech vaccines up until 14 April and found a possible association between the AZ shot …

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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 …

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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 …

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Sanofi eyes 2022 filing for haemophilia drug fitusiran, despite safety issue

Sanofi’s much anticipated drug for both haemophilia A and B – fitusiran – could be filed in 2022 despite a problem with blood clots in some patients in late-stage testing.  In its quarterly results update, Sanofi notes that a revised dosing schedule is being tested in its phase 3 programme to try to reduce the …

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bluebird bio ‘baffled’ after NICE rejects beta-thalassaemia gene therapy

It’s back to the drawing board for bluebird bio and its discussions with NICE, which has rejected its beta thalassaemia gene therapy Zynteglo for regular NHS use in first draft guidance. NICE is assessing Zynteglo (betibeglogene autotemcel), a one-off gene therapy for the condition, which can have life-threatening consequences and is associated with a curtailed …

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NICE reverses stance on Celgene’s Revlimid for myeloma maintenance

NHS patients in England with newly-diagnosed multiple myeloma can be treated with Celgene’s Revlimid as maintenance therapy after a stem cell transplant, after new guidance from NICE. The cost-effectiveness agency has backed interim funding for Revlimid (lenalidomide) in this setting via the Cancer Drugs Fund (CDF), which provides temporary reimbursement for medicines until further data …

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Chasing BMS, J&J files BCMA CAR-T for multiple myeloma to FDA

Johnson & Johnson’s Janssen unit has filed a rolling submission for its multiple myeloma CAR-T ciltacabtagene autoleucel (cilta-cel) to the FDA, in hot pursuit of Bristol-Myers Squibb’s delayed rival therapy. Cilta-cel – which targets B-cell maturation antigen (BCMA) – has been submitted as a treatment for patients with relapsed or refractory myeloma, an incurable form …

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Bluebird trumpets long-term data from beta-thalassaemia gene therapy

bluebird bio has presented long-term data from its Zinteglo one-time gene therapy for the blood disorder beta-thalassaemia, as the company continues talks with payers in Europe to bring the ultra-pricey treatment to market. The European Medicines Agency (EMA) has granted a conditional marketing authorisation for the drug that will be marketed as Zinteglo (betibeglogene autotemcel), …

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GSK moves further ahead in BCMA with EU okay for Blenrep

GlaxoSmithKline has approval on both sides of the Atlantic for its multiple myeloma drug Blenrep, after getting the nod from the European Commission. Blenrep (belantamab mafodotin) becomes the first BCMA-targeted drug for myeloma to be approved in the EU, and according to its label can be used to treat the blood cancer in adult patients …

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Novartis eyes filings for leukaemia drug asciminib after phase 3 win

A first-in-class STAMP inhibitor developed by Novartis – asciminib – has outperformed a current drug for chronic myeloid leukaemia (CML) in a head-to-head trial, setting up regulatory filings. The ASCEMBL trial compared asciminib (ABL001) to Pfizer’s Bosulif (bosutinib) in Philadelphia chromosome-positive CML patients who had previously been treated with two or more tyrosine kinase inhibitors …

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How to increase haematologists’ and oncologists’ confidence with new treatments

A new whitepaper from Medscape highlights the difficulties haematologists and oncologists face in keeping up with rapid developments in treatment. We speak to the company’s Katie Lucero and Victoria Harvey-Jones to find out how independent medical education is changing to help HCPs increase their confidence in treating cancer patients. It’s an exciting time to be …

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