Overview
- CHMP adopted a positive opinion on 17 September recommending a change to Enhertu’s marketing authorisation that must be confirmed by the European Commission before it becomes binding.
- The new adjuvant indication covers Enhertu as a single agent for adults with resected HER2‑positive breast cancer who have residual invasive disease after neoadjuvant taxane‑based and HER2‑targeted therapy.
- The opinion also sets out a broader set of indications that would formalise use across metastatic HER2‑positive disease, HER2‑low and HER2‑ultralow breast cancers, HER2‑mutant non‑small cell lung cancer, HER2‑positive gastric cancer and other HER2‑positive solid tumours.
- Enhertu (trastuzumab deruxtecan), marketed by Daiichi Sankyo Europe GmbH, remains under conditional marketing authorisation and additional monitoring so detailed prescribing guidance will appear in the updated SmPC after the Commission decides.
- The CHMP opinion could expand patient access in the EU and trigger payer and health‑system decisions on reimbursement and rollout while regulators continue to collect more safety and effectiveness data.