EU Approves Etcamah in First-Line ER+ Breast Cancer

AstraZeneca has secured EU approval for Etcamah (camizestrant) in combination with CDK4/6 inhibitors as a first-line treatment for ER-positive, HER2-negative advanced breast cancer in patients with ESR1 mutations, marking a key expansion of its oncology portfolio. The decision follows data from the SERENA-6 Phase III trial showing a 56% reduction in the risk of disease progression or death and a median progression-free survival of 16.0 months versus 9.2 months with standard therapy. Etcamah is already approved in Japan, the UAE, and Saudi Arabia, with additional regulatory reviews underway, including in the United States. Company filings and press material emphasize that Etcamah is the first and only next-generation oral SERD approved in this frontline setting in combination with widely used CDK4/6 inhibitors. The EU approval reinforces AstraZeneca’s strategy to broaden precision-oncology options amid ongoing efforts to address endocrine resistance in hormone receptor–positive breast cancer. The U.S. FDA review remains ongoing as the company continues to present updated trial results to support broader use.