Novartis’ Scemblix (asciminib) Receives EC’s Approval for the Treatment of Chronic Myeloid Leukemia
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
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