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

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

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  • 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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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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