Shots:

• The EC has approved Scemblix for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) in adult patients prior treated with two or more TKIs
• The approval was based on the P-III (ASCEMBL) trial evaluating Scemblix vs Bosulif which showed an MMR rate (25.5% vs 13.2%), the discontinuation rate due to adverse reactions (5.8% vs 21.1%) at the 24wk. In the 96wk. longer-term follow-up, MMR rate (37.6% vs 15.8%) & the discontinuation rate was 7.7% vs 26.3%  
• The approval will be valid for all 27 EU member states, Iceland, Norway & Liechtenstein. The therapy was approved in multiple countries outside the US, incl. Japan, Switzerland & the UK for Ph+ CML-CP

Ref: Novartis | Image: Novartis