Overview
- On 16 October 2025, the EMA’s CHMP issued a positive opinion to change the marketing authorisation for Scemblix.
- The updated indication covers treatment of adults with Philadelphia chromosome‑positive chronic‑phase CML who have received two or more prior tyrosine kinase inhibitors.
- Scemblix contains the active substance asciminib hydrochloride (asciminib).
- The marketing authorisation holder is Novartis Europharm Limited, and the medicine remains under additional monitoring.
- Scemblix retains orphan‑medicine status, and the EMA will publish an updated SmPC in all EU languages after the European Commission’s decision.