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#ADC/偶联药物

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Oct 1Thu
  1. BioCentury59

    I-DXd withdrawal thins October PDUFA calendar

    Merck & Co. and Daiichi Sankyo withdrew their BLA for ifinatamab deruxtecan two weeks before its PDUFA date; the partners had sought accelerated approval for extensive-stage small cell lung cancer in patients whose disease progressed on platinum chemotherapy. The withdrawal leaves at least five FDA decisions on the PDUFA calendar for October. The article does not state what the companies plan to do next with the programme.

    Why it matters: A BLA withdrawal by Merck and Daiichi Sankyo cuts October's expected FDA decision count to five.

Sep 30Wed
  1. biospace.com50

    Merck, Daiichi Sankyo retract accelerated approval request for lung cancer ADC

    Merck and Daiichi Sankyo have voluntarily withdrawn their accelerated approval application for the antibody-drug conjugate ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer after platinum-based chemotherapy, after the FDA said the data did not satisfy requirements for the proposed indication. The application rested on a 48.2% confirmed objective response rate from the Phase 2 IDeate-Lung01 study. A Phase 3 trial in ES-SCLC with enrollment nearing completion continues and could support a future filing.

    Why it matters: Voluntary withdrawal of an accelerated approval application narrows the regulatory path for a key Merck-Daiichi Sankyo ADC.

Sep 28Mon
  1. biopharmadive.com56

    Merck, Daiichi end plans to seek speedy approval of lung cancer ADC

    Merck & Co. and Daiichi Sankyo withdrew their U.S. application for accelerated approval of ifinatamab deruxtecan, or I-DXd, in extensive-stage small-cell lung cancer after the FDA indicated Phase 2 response rate data were insufficient; a decision had been expected by Oct. 10. The B7-H3-targeting drug is still being tested against chemotherapy in relapsed disease, a trial in which recruitment was temporarily halted last year after higher than anticipated deaths from a serious lung condition. Competing B7-H3 drugs licensed to GSK (riz-rez) and Roche (tam-peli) have advanced, and I-DXd is also in Phase 3 testing in prostate cancer and esophageal squamous cell carcinoma.

    Why it matters: A rejected accelerated approval reshapes the B7-H3 race in small-cell lung cancer among Merck, GSK and Roche.

Sep 17Thu
  1. STAT News57

    STAT+: England to cover AstraZeneca breast cancer drug, a result of U.K.-U.S. drug pricing deal

    English health authorities agreed to provide AstraZeneca's Enhertu through the NHS for women with metastatic breast cancer whose tumors have low levels of HER2, ending a years-long dispute. The decision extends the antibody-drug conjugate to an estimated 1,000 people in England and follows a U.S.-U.K. drug pricing deal under which a U.K. health agency raised cost-effectiveness thresholds. Scotland has covered the drug since 2023, as have 26 other European countries.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org