USFDAMay 1, 2026, 09:17 AM
AZN Camizestrant Fails FDA ODAC Vote for Breast Cancer
AI Summary
AstraZeneca announced that the US FDA's Oncologic Drugs Advisory Committee (ODAC) did not reach a majority vote (3 to 6) in favor of the benefit-risk profile of camizestrant in combination with a CDK4/6 inhibitor for 1st-line treatment of HR-positive, HER2-negative advanced breast cancer patients with emergent ESR1 mutations. This decision, based on the SERENA-6 Phase III trial, is a setback for the drug's US approval, despite the trial showing a 56% reduction in disease progression or death risk and improved median PFS. AstraZeneca expressed disappointment but remains confident in the clinical benefit and will continue to work with the FDA, which is not bound by the committee's advice.
Key Highlights
- FDA ODAC voted 3 to 6 against AstraZeneca's camizestrant benefit-risk profile.
- Camizestrant is for 1st-line HR-positive, HER2-negative advanced breast cancer with emergent ESR1 mutation.
- SERENA-6 Phase III trial showed a 56% reduction in disease progression or death risk (HR 0.44).
- Median PFS was 16.0 months for camizestrant combination vs. 9.2 months for comparator.
- PFS2 demonstrated a benefit of 25.7 months for camizestrant vs. 19.1 months for comparator.
- The FDA is not bound by the ODAC vote; AstraZeneca will continue to work with the agency.
- Regulatory applications for camizestrant are also under review in the EU, Japan, and other countries.