The FDA granted accelerated approval to camizestrant (Etcamah, AstraZeneca) on September 4, 2026, for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer when an ESR1 mutation is detected during aromatase-inhibitor and CDK4/6-inhibitor treatment, using an FDA-authorized test.
Camizestrant is an estrogen receptor antagonist and is used with one of three CDK4/6 inhibitors:
abemaciclib, palbociclib, or ribociclib.
The approval was based on the Phase 3 SERENA-6 trial. At a planned interim analysis, the camizestrant combination reduced the risk of disease progression or death by 56% versus continuing an aromatase inhibitor with a CDK4/6 inhibitor; median progression-free survival was 16.0 months versus 9.2 months.
The approval is accelerated and based on progression-free survival after ESR1 mutation detection. Continued approval may depend on confirmatory evidence verifying clinical benefit; overall-survival data were not mature at the interim analysis.
The FDA advisory committee did not reach a majority in favor of the benefit-risk profile, but the FDA proceeded with approval.
Sources:
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