FDA grants accelerated approval for Etcamah combo therapy for advanced HR-positive, HER2-negative breast cancer

The U.S. Food and Drug Administration announced accelerated approval of Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for adult patients with hormone-receptor-positive, HER2-negative locally advanced or metastatic breast cancer that carry an ESR1 mutation.

The approval is tied to detection of the ESR1 mutation using an FDA-authorized test after disease progression on aromatase inhibitor and CDK4/6 inhibitor therapy.

ESR1 mutations are acquired resistance changes; they are found in fewer than 5% of patients at diagnosis but emerge in roughly 40% after progression on aromatase inhibitors.

Acting FDA Commissioner Kyle Diamantas said the decision adds an important new option for women living with metastatic breast cancer.