The FDA granted accelerated approval to AstraZeneca’s next-generation oral SERD camizestrant (Etcamah) for a defined group of HR+/HER2– advanced breast cancer patients with ESR1 mutations, despite an April advisory committee vote against the drug. Coverage described the approval as based on the SERENA-6 Phase 3 trial’s progression-free survival primary endpoint, while the adcomm had raised concerns about the clinical meaning of the randomized treatment switch at an earlier timepoint tied to mutation testing. The FDA’s decision also pairs Etcamah with Guardant Health’s Guardant360 companion diagnostic assay to identify patients with ESR1 mutations during aromatase inhibitor plus CDK4/6 inhibitor therapy. Industry commentary around the approval emphasized that revenues could be “modest” relative to expectations, while attention shifts to ongoing and upcoming late-stage readouts that may clarify overall survival and broader label expansion.