ETCAMAH (Camizestrant) - (SERENA-6)

September 4, 2026: AstraZeneca (NYSE: AZN) said the FDA granted accelerated approval to ETCAMAH (camizestrant) plus a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer when an ESR1 mutation is detected during aromatase inhibitor plus CDK4/6 inhibitor therapy using an FDA-authorized test. The FDA also approved a companion diagnostic to detect emerging ESR1 mutations in ctDNA.

Approval was based on the Phase III SERENA-6 trial. In a planned interim analysis, the camizestrant combination reduced risk of progression or death by 56% versus AI plus CDK4/6 inhibitor (HR 0.44; 95% CI 0.31-0.60; p<0.00001), with median PFS 16.0 vs 9.2 months. A subsequent pre-planned analysis showed statistically significant PFS2 benefit of 25.7 vs 19.1 months (HR 0.63; 95% CI 0.46-0.86; p=0.00373). OS remained immature but trended in favor of camizestrant (HR 0.87; 95% CI 0.57-1.30); the trial continues to assess OS.

Results were presented at the 2025 ASCO Annual Meeting and published in The New England Journal of Medicine. Safety was consistent with known profiles, with no new safety concerns identified.