The U.S. FDA has granted accelerated approval to AstraZeneca’s Etcamah, in combination with a CDK4/6 inhibitor, for 1st-line advanced HR-positive breast cancer.
Etcamah — an oral selective estrogen receptor degrader (SERD) and complete ER antagonist —in combination with a CDK 4/6 inhibitor (abemaciclib, palbociclib or ribociclib) has been approved for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor (AI) and CDK4/6 inhibitor therapy, based on a FDA-authorized test.
The accelerated approval was based on results from the pivotal SERENA-6 phase 3 trial presented at the 2025 ASCO Annual Meeting and simultaneously published in The New England Journal of Medicine. In a planned interim analysis of the SERENA-6 trial, Etcamah in combination with a CDK4/6 inhibitor reduced the risk of disease progression or death by 56% versus standard-of-care treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor.