FDA Grants Accelerated Approval to New Breast Cancer Treatment Etcamah (Camizestrant)

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 upon detection of an estrogen receptor-1 (ESR1) mutation. This marks the first FDA approval of a cancer therapy guided by the detection of a resistance mutation in circulating tumor DNA (ctDNA) before imaging tests show disease progression.