FDA Approves Camizestrant Plus a CDK4/6 Inhibitor for Emergent ESR1-Mutated HR+, HER2

The FDA has granted accelerated approval to camizestrant combined with a CDK4/6 inhibitor for treating adult patients with hormone receptor–positive, HER2-negative metastatic breast cancer that develops an ESR1 mutation during treatment. This decision was supported by phase 3 SERENA-6 trial data showing a significant improvement in progression-free survival compared to the current standard of care.

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