Other Events ·
FDA approves AZN's Etcamah for HR-positive breast cancer with ESR1 mutation
AZNAstrazeneca PLC
The US FDA approved Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer upon detection of an emergent ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy. This accelerated approval is based on the SERENA-6 Phase III trial results, which demonstrated a 56% reduction in the risk of disease progression or death (HR: 0.44) compared to standard-of-care treatment. The filing also notes that the FDA concurrently approved a companion diagnostic test for detecting ESR1 mutations via circulating tumor DNA. AstraZeneca PLC is a global biopharmaceutical company focused on discovering, developing, and commercializing prescription medicines in oncology, rare disease, and bio-pharmaceuticals.