Primary-source record
Decision-gradeFDA approval
AstraZeneca PLC · FDA approves Etcamah (camizestrant)
FDA lists Etcamah (camizestrant) as novel drug approval #38 of 2026 on 2026-09-04: To treat hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy
Key facts
- Filed
- Sep 4, 2026, 12:00 AM
- Event
- FDA approval
- Direction
- Positive
- Company
AZNAstraZeneca- Asset
- camizestrant
- Source
- FDA Novel Drug Approvals
- Confidence
- Sourced