Novartis Receives European Commission Approval for Scemblix as First-Line CML Treatment

Novartis today announced that the European Commission has approved Scemblix (asciminib) for the treatment of adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) in the European Union. The approval was based on results from the Phase 3 ASC4FIRST trial, which demonstrated superior major molecular response rates compared to standard-of-care TKIs. This approval makes Scemblix available as a first-line treatment option for CML patients across all EU member states. Novartis continues to study asciminib in other CML settings.