The Food and Drug Administration granted accelerated approval to Etcamah, or camizestrant, in combination with a CDK4/6 inhibitor for certain patients with advanced breast cancer.
The treatment is intended for HR-positive, HER2-negative disease when an ESR1 resistance mutation is detected during therapy using an FDA-authorized test. The agency also authorized the Guardant360 CDx assay as a companion diagnostic.
FDA said the approval is the first for a cancer therapy guided by detection of a resistance mutation in circulating tumor DNA before imaging shows disease progression. Confirmatory studies are required to verify clinical benefit.