AstraZeneca Wins FDA Approval for Etcamah, Cutting Cancer Progression Risk 56%

The FDA granted accelerated approval to AstraZeneca’s Etcamah (camizestrant) for adults with HR-positive, HER2-negative advanced breast cancer. This approval targets patients whose tumors develop an ESR1 mutation during initial treatment with aromatase and CDK4/6 inhibitors.

Data from the SERENA-6 Phase III trial supported the decision. Switching to Etcamah plus a CDK4/6 inhibitor reduced the risk of disease progression or death by 56%. Median progression-free survival reached 16.0 months for the Etcamah group. The control group showed a median progression-free survival of 9.2 months.

The strategy relies on detecting resistance mutations in circulating tumor DNA (ctDNA) before radiographic progression occurs. The FDA also approved the Guardant360 CDx blood test as a companion diagnostic to identify eligible patients.