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#阿斯利康

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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.

Sep 11Fri
  1. nature.com61

    Selective oestrogen receptor degrader class grows with new cancer approval

    The FDA has approved AstraZeneca's camizestrant (Etcamah), a selective oestrogen receptor degrader, as part of a combination therapy for a subset of breast cancer patients. The drug targets patients whose tumours have acquired resistance mutations to aromatase inhibitors. It expands the SERD class of therapies.

    Why it matters: FDA approval of a new SERD widens treatment options for aromatase inhibitor-resistant breast cancer.

Sep 5Sat
  1. fda.gov59

    FDA Grants Accelerated Approval to a New Breast Cancer Treatment

    The FDA granted accelerated approval to AstraZeneca's Etcamah (camizestrant), an oral tablet, combined with a CDK4/6 inhibitor (abemaciclib, palbociclib or ribociclib) for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer whose tumors show an ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, detected by the FDA-authorized Guardant360 CDx companion diagnostic. In the pivotal trial, estimated median progression-free survival was 16 months versus 9.2 months for continuing an aromatase inhibitor plus a CDK4/6 inhibitor. The label carries a boxed warning for irregular heart rhythm, and confirmatory trials are required to verify clinical benefit.

    Why it matters: First FDA approval of a cancer therapy guided by ctDNA resistance-mutation detection before imaging shows progression.

Aug 24Mon
  1. FiercePharma56

    Merck, AZ lawsuits against Medicare price negotiations swatted down

    The U.S. Court of Appeals for the Third Circuit rejected Merck's claim that the CMS Medicare drug price negotiation program under the Inflation Reduction Act violates the First and Fifth Amendments, with Judge Colleen Kollar-Kotelly ruling companies can choose whether to participate. Five days earlier, a federal court in Maryland dismissed an AstraZeneca suit over how CMS grouped its drugs for eligibility. The rulings extend a string of losses for drugmakers since 2022, though Teva won a partial reversal last week when an appeals court sent its case back to District Court.

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