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 treatment, supporting the FDA’s decision despite the panel’s concerns.
The accelerated approval requires AstraZeneca to provide confirmatory evidence. The FDA also cleared Guardant360 CDx as a companion liquid-biopsy test to identify emerging ESR1 mutations.
Sources:
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