FDA panel rebuffs AstraZeneca's early ESR1-driven camizestrant approach in breast cancer
TL;DR
An FDA advisory panel voted 6-3 against approving AstraZeneca's oral SERD camizestrant for HR-positive, HER2-negative metastatic breast cancer with ESR1 mutations detected before progression, citing insufficient evidence of a meaningful long-term benefit and trial-design concerns (no crossover, OS data immature). Approval now seems unlikely despite a progression-free survival improvement seen in Serena-6.
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- FDA ODAC Votes Against Clinical Benefit of Switching to Camizestrant in HR+ Breast Cancer After ESR1 Mutation Detection OncLive
- AstraZeneca’s Breast-Cancer Candidate Drug Loses FDA Panel Vote WSJ
- FDA revives oncology advisory panel to debate AstraZeneca drugs Endpoints News
- FDA Panel Gives Thumbs Down to Novel Strategy for Switching Breast Cancer Therapy MedPage Today
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