FDA Grants Accelerated Approval to Etcamah for ESR1-Mutated Advanced Breast Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. This approval is specifically for cases where an estrogen receptor-1 (ESR1) mutation is detected during aromatase inhibitor and CDK4/6 inhibitor therapy, making it the first cancer therapy approved based on detecting a resistance mutation in circulating tumor DNA (ctDNA) before radiographic disease progression.