The European Medicines Agency’s CHMP has recommended approval of camizestrant combined with a CDK4/6 inhibitor for patients with ER-positive, HER2-negative advanced breast cancer who develop ESR1 mutations before disease progression. The recommendation is based on results from the Phase 3 SERENA-6 trial, which used regular liquid biopsies to detect ESR1 mutations early.
Patients who switched from an aromatase inhibitor to camizestrant after mutation detection had a 56% lower risk of disease progression or death compared with those who stayed on standard therapy. Median progression-free survival improved from 9.2 months to 16 months. Benefits were seen across all patient groups.
The treatment was generally well tolerated. Some patients experienced mild photopsia or slow heart rate. While European regulators supported approval, the U.S. FDA remains cautious, with advisers questioning whether the therapy improves overall survival despite delaying disease progression.