The FDA has delayed its decision on AstraZeneca's experimental breast cancer pill camizestrant after a negative advisory committee vote in April 2026.
The FDA's Oncologic Drugs Advisory Committee (ODAC) voted 6 to 3 against camizestrant, finding the trial data did not show a clinically meaningful benefit.
Regulators raised concerns about the design of the SERENA‑6 Phase III trial and requested additional data, including analyses on long‑term efficacy outcomes.
AstraZeneca has submitted further analyses requested by the FDA but has not disclosed the length of the review extension or a new target decision date.
Analysts believe approval based on the current trial results is unlikely, even though the FDA is not bound by the committee's recommendation.
The delay is a setback for AstraZeneca's plan to position camizestrant as a potential blockbuster in HR‑positive, HER2‑negative advanced breast cancer.
Sources:
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