EMA Recommends Etcamah for ESR1‑Mutant Advanced Breast Cancer

Overview

• The Committee for Medicinal Products for Human Use adopted a positive opinion on 21 May 2026, recommending marketing authorisation for Etcamah (camizestrant) to treat ER‑positive, HER2‑negative locally advanced or metastatic breast cancer with acquired ESR1 mutations.
• Interim results from the phase 3 SERENA‑6 trial published in the New England Journal of Medicine found median progression‑free survival of 16 months for patients switched to camizestrant plus continued CDK4/6 inhibitor versus 9.2 months for those who stayed on an aromatase inhibitor plus a CDK4/6 inhibitor.
• Camizestrant is an oral next‑generation selective oestrogen receptor degrader that blocks and triggers proteasome‑dependent degradation of ERα encoded by both wild‑type and mutant ESR1, and Etcamah will be supplied as 75 mg film‑coated tablets for use with a CDK4/6 inhibitor.
• The most common adverse effects reported with Etcamah plus a CDK4/6 inhibitor include neutropenia, visual disturbances, infections, anaemia, diarrhoea, nausea, fatigue, bradycardia and leukopenia, and pre‑ or peri‑menopausal women and men should also receive LHRH suppression when treated.
• A US FDA advisory panel voted against approval last month because of concerns about the trial design rather than drug safety or observed benefit, creating a likely regulatory split to watch as the European Commission reviews the CHMP opinion and the SmPC is prepared.