Drug Approval | May 30, 2026
FDA delays AstraZeneca decision on camizestrant as regulators seek more data
The filing is backed by results from the pivotal SERENA-6 Phase III trial
The filing is backed by results from the pivotal SERENA-6 Phase III trial
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 3 to 6 against recommending camizestrant in combination with a CDK4/6 inhibitor
The Committee backed the combination based on results from the CAPItello-281 Phase III trial, marking a key milestone in the regulatory pathway for AstraZeneca’s targeted therapy strategy in prostate cancer
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
AstraZeneca and Merck are committed to working with the FDA to bring LYNPARZA in combination with abi/pred to patients diagnosed with mCRPC.
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