The FDA approved AstraZeneca’s oral SERD camizestrant (sold as Etcamah) for a subset of patients with HR+/HER2− advanced breast cancer with ESR1 mutations detected during aromatase inhibitor and CDK4/6 inhibitor therapy. The decision came despite a negative advisory committee vote earlier this year. Etcamah’s approval is based on SERENA-6, where patients in the tested arm saw a 56% reduction in the risk of death or disease progression versus controls; overall survival data remain immature. The agency’s approval opens a “modest” revenue path according to analysts, while also highlighting how evidence on switching paradigms can still support review outcomes. The back-and-forth between the adcomm and FDA illustrates persistent scrutiny around trial design—especially the timing of ESR1 testing and regimen switches. For AstraZeneca, the FDA decision creates momentum as the oral SERD competes alongside other ESR1-targeted and combination strategies in advanced hormone receptor–positive disease.