AstraZeneca Wins FDA Approval for Etcamah, a First for Liquid Biopsies

The FDA granted accelerated approval to AstraZeneca’s camizestrant, marketed under the brand name Etcamah. The therapy treats adult patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer harboring an ESR1 mutation.

Patients receive Etcamah in combination with a CDK4/6 inhibitor. This decision represents the first FDA approval for a cancer therapy based on resistance mutations detected via liquid biopsy before imaging scans show disease progression.

The new protocol allows clinicians to adjust treatment strategies earlier in the disease cycle. The FDA based its decision on data from the Phase 3 SERENA-6 clinical trial.