On September 4, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Etcamah (camizestrant) administered in combination with a CDK4/6 inhibitor for adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer harboring the ESR1 mutation. This approval targets patients whose ESR1 mutation was detected during prior aromatase inhibitor and CDK4/6 inhibitor therapy.

Etcamah is to be used alongside one of the CDK4/6 inhibitors including abemaciclib, palbociclib, or ribociclib. This regimen represents an important therapeutic option for a subset of patients with advanced breast cancer characterized by specific molecular alterations.

Healthcare professionals should consider this new approval as part of clinical management and prescribing decisions for eligible patients. The FDA’s announcement underscores the ongoing commitment to advancing targeted therapies in oncology based on molecular diagnostics and patient-specific factors.