FDA Panel Rejects AstraZeneca’s Camizestrant, Shares Drop 2%
AZN•AstraZeneca shares fell 2% after an FDA advisory panel voted 6-3 against approving its breast cancer drug camizestrant, citing trial-design concerns despite Phase 3 SERENA-6 data. SERENA-6 showed a 56% reduction in progression risk and median PFS of 16 versus 9.2 months, and the company will continue FDA discussions.
1. FDA Advisory Panel Vote
An FDA Oncology Drugs Advisory Committee voted 6-3 against approving camizestrant for ESR1-mutant metastatic breast cancer, leading AstraZeneca shares to drop 2% in London trading. Advisers questioned whether switching patients before visible progression demonstrated a lasting survival benefit.
2. SERENA-6 Phase 3 Results
The SERENA-6 trial showed camizestrant cut the risk of disease progression or death by 56% versus standard care, with median progression-free survival of 16 months compared with 9.2 months. No major safety or toxicity concerns were raised during the review.
3. Company Response and Outlook
AstraZeneca affirmed its confidence in camizestrant’s data and will continue discussions with the FDA ahead of a final decision. The company also reported Q1 revenue of $15.29 billion, up 13% year-on-year, driven by oncology division growth and remains on track for its 2030 targets.
