Breast Cancer Drug Wins Approval Despite Rejection by Agency Advisors

— Oral SERD camizestrant lands indication for use in novel first-line treatment strategy

September 8, 2026

• 2 min read

The FDA on Friday granted accelerated approval to camizestrant (Etcamah) for treating hormone receptor-positive/HER2-negative breast cancer at the first sign of ESR1 resistance mutations during first-line treatment.

Camizestrant is an oral selective estrogen receptor degrader (SERD) with an indication that stipulates use in combination with a CDK4/6 inhibitor when these mutations have been detected during combination treatment with an aromatase inhibitor (AI) and CDK4/6 inhibitor.