FDA approves Etcamah for ESR1-mutated breast cancer

The U.S. Food & Drug Administration has granted accelerated approval to Etcamah (camizestrant) for adults with hormone receptor (HR)-positive/HER2-negative, locally advanced or metastatic breast cancer. The treatment is specifically indicated for patients who have acquired an estrogen receptor-1 (ESR1) mutation during therapy with an aromatase inhibitor and a CDK4/6 inhibitor.

Etcamah is a next-generation oral selective estrogen receptor degrader (SERD) that works by binding to and breaking down estrogen receptors to slow cancer progression. The approval is based on results from the phase 3 SERENA-6 clinical trial, which demonstrated a median progression-free survival of 16 months when Etcamah was used in combination with a CDK4/6 inhibitor, compared to 9.2 months for those using an aromatase inhibitor plus a CDK4/6 inhibitor.

Medical experts suggest that clinicians may benefit from switching to camizestrant at the emergence of subclinical ESR1 mutations rather than waiting for radiographic progression. This approach aims to deploy highly effective agents earlier to prevent the development of further resistance.