Category: Enhertu

  • ASCO22: Enhertu aces key HER2-low test in breast cancer

    In February, AstraZeneca and Daiichi Sankyo teased the results of their pivotal trial of Enhertu in HER2-low breast cancer, and, at ASCO, they finally revealed the data – with the numbers every bit as good as hoped. The top-line results of DESTINY Breast-04 are impressive – in patients with HER2-low metastatic breast cancer who received […]

  • AstraZeneca, Daiichi Sankyo have high hopes for drug that goes low in breast cancer

    During the annual meeting of the American Society of Clinical Oncology, AstraZeneca and Daiichi Sankyo reported pivotal clinical trial data showing that their partnered cancer drug Enhertu can treat a group of patients previously thought to be out of reach for a targeted therapy. The results suggest use of this FDA-approved drug could significantly expand […]

  • SEC accuses former AstraZeneca exec of insider trading

    The US Securities and Exchange Commission has sued a former AstraZeneca executive over alleged insider trading in connection with its 2019 deal to acquire rights to Daiichi Sankyo’s breast cancer therapy Enhertu. The complaint was filed against Hugues Pierre Joublin (54) – formerly global head of corporate affairs for oncology at AZ until his role […]

  • Enhertu gets breakthrough tag in HER2-low breast cancer

    AstraZeneca and Daiichi Sankyo have claimed a fifth breakthrough designation from the FDA for Enhertu, shortly after the showing the drug extended survival in patients with HER2-low metastatic breast cancer. The coveted status has been awarded to the HER2-targeting antibody-drug conjugate (ADC) on the back of the DESTINY-Breast04 trial results, unveiled in February, which involved […]

  • FDA starts speedy review of Enhertu in lung cancer

    AstraZeneca and Daiichi Sankyo should only have to wait for six months to hear from the FDA if it will approve their HER2 drug Enhertu for non-small cell lung cancer (NSCLC) and add to its current uses in breast and gastric cancer. The US regulator has kicked off a priority review of Enhertu (trastuzumab deruxtecan) […]

  • Seagen wins Enhertu patent dispute with Daiichi Sankyo

    A US jury has decided that Daiichi Sankyo and AstraZeneca’s breast cancer drug Enhertu infringes a patent held by US biotech Seagen, awarding almost $42 million in damages. Seagen claims Enhertu (trastuzumab deruxtecan) – an antibody-drug conjugate (ADC) targeting HER2 – infringes a patient it holds (No. 10,808,039) covering ADCs that include auristatin compounds coupled […]

  • Big day for AZ, Daiichi as Enhertu aces HER2-low breast cancer trial

    Already making inroads as a treatment for HER2-positive breast cancer, AstraZeneca and Daiichi Sankyo’s Enhertu has now shown efficacy in tumours that express lower levels of HER2 – potentially making it an option for a much broader group of patients. It’s a key moment for the two companies, as expansion into HER2-low breast cancer has […]

  • EMA starts review of Enhertu for HER2+ gastric cancer

    The EMA has started its review of AstraZeneca and Daiichi Sankyo’s Enhertu for a second indication, as a second-line treatment for HER2-positive gastric cancer. If approved the new indication for antibody-drug conjugate Enhertu (trastuzumab deruxtecan) will add to its first EU approval in advanced HER2-positive breast cancer after two or more HER2-targeted therapies. Around one […]

  • Enhertu nabs speedy FDA review for earlier use in breast cancer

    Hard on the heels of impressive new data for Enhertu as a second-line therapy for breast cancer, AstraZeneca and Daichi Sankyo have claimed FDA breakthrough status for the drug that should shorten its review time. The new designation for Enhertu (trastuzumab deruxtecan) is based on the results of the DESTINY-Breast03 trial, which showed that the […]

  • 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 […]

  • 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 […]

  • 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 […]

  • 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 […]

  • Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receives EU’s Approval for the HER2 Positive Metastatic Breast Cancer

    Shots: The approval is based on pivotal P-II DESTINY-Breast01 study involves assessing of Enhertu (5.4 mg/kg) in 184 patients as a monothx. for patients with unresectable/m-HER2+ BC prior treated with trastuzumab emtansine Results: @median follow up of 20.5mos., ORR (61.4%); CRR (54.9%); mDoR (20.8mos.). The safety of therapy has been evaluated in a pooled analysis […]

  • Biohaven’s Troriluzole Failure; Daiichi/ AZ’s Enhertu; Fujifilm & Manufacturing Spree; J&J’s Darzalex Faspro

    Biohaven’s Troriluzole Dwindles Again In Alzheimer’s After Anxiety  Biohaven Pharmaceuticals had put too much faith in its third-generation prodrug, Troriluzole. The company has tested the efficacy of the drug in more than one indication, including generalized anxiety disorder (GAD), obsessive-compulsive disorder, spinocerebellar ataxia and Alzheimer’s disease (AD). However, it seems the drug continues to disappoint […]

  • AZ/Daiichi Sankyo’s Enhertu gets second US cancer indication

    AstraZeneca and Daiichi Sankyo’s Enhertu cancer drug has picked up a second indication, in patients who have stomach cancer and haven’t responded to Roche’s Herceptin (trastuzumab). This latest indication adds to Enhertu first approval at the end of 2019 for advanced HER2-positive breast cancer after two or more HER2-targeted regimens. Around one in five gastric […]

  • Daiichi Sankyo, AZ close on EU approval of Enhertu for breast cancer

    Daiichi Sankyo and AstraZeneca could be just weeks away from an EU approval for their antibody-drug conjugate (ADC) for breast cancer – Enhertu – which is tipped to become a multibillion-dollar blockbuster. At its meeting last week, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Enhertu (trastuzumab deruxtecan) for patients […]

  • AstraZeneca to Unveil its Robust Pipeline of Breast Cancer at SABCS

    Shots: AstraZeneca will divulge new developments across BC at the 2020 SABCS. The key abstract includes data of P-ll DESTINY-Breast01 study reinforcing the efficacy seen with Enhertu in HER2+ mBC following 2+ prior anti-HER2 based regimens The company will present data of P-I SERENA-1 study demonstrating the efficacy & safety of AZD9833 as a monothx. […]