FDA Approves Camizestrant for Breast Cancer Over Advisory Committee Objections
On September 4, 2026, the FDA granted accelerated approval to AstraZeneca's camizestrant (Etcamah) for ESR1-mutated hormone-receptor-positive, HER2-negative metastatic breast cancer, making it the first cancer therapy triggered by a resistance mutation detected in circulating tumor DNA before imaging confirms progression. The approval came despite a 3–6 advisory committee vote finding clinical benefit unproven, with the FDA acknowledging that overall-survival data remain immature and that switching treatment at molecular detection rather than at radiographic progression has not yet been shown to produce a clinically meaningful long-term outcome. Continued approval depends on confirmatory trial results, though the FDA has not publicly named the required study or its timeline.