U.S.
FDA Grants Accelerated Approval to a New Breast Cancer Treatment
Facts
- The U.S. Food and Drug Administration granted accelerated approval to Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for the treatment of adult patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer. [1]
- The FDA also authorized the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer with ESR1 mutations for treatment with camizestrant. [1]
- The accelerated approval was granted to AstraZeneca. [1]
- At the diagnosis of HR-positive metastatic breast cancer, fewer than 5 percent of patients will have the ESR1 tumor mutation. [1]
- After disease progression on an aromatase inhibitor, nearly 40 percent of patients will have the ESR1 tumor mutation. [1]
- Estimated median progression-free survival was 16 months in the Etcamah and CDK4/6 inhibitor arm and 9.2 months in the aromatase inhibitor and CDK4/6 inhibitor arm. [1]