Talk Bio

The FDA granted accelerated approval on September 4, 2026, to AstraZeneca’s camizestrant, marketed as Etcamah, in combination with a CDK4/6 inhibitor—abemaciclib, palbociclib, or ribociclib. The approval covers adults with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer whose tumors develop an ESR1 mutation while receiving an aromatase inhibitor plus a CDK4/6 inhibitor. The decision followed a 6–3 negative vote by the FDA’s Oncologic Drugs Advisory Committee in April. The committee’s recommendation was nonbinding, allowing the FDA to reach a different conclusion. Advisers questioned the SERENA-6 trial’s design, the absence of mature overall-survival data, quality-of-life evidence, and whether changing therapy based on circulating-tumor-DNA results before radiographic progression provides a clinically meaningful benefit. SERENA-6 reportedly showed a 56% reduction in the risk of disease progression or death versus continuing standard treatmen...