Novartis receives positive CHMP opinion for Scemblix®, a novel ...

June 24, 2022

Scemblix® (asciminib), with a unique STAMP mechanism, offers a new treatment for CML patients in Europe resistant or intolerant to prior TKIs. The CHMP's positive opinion, based on Phase III ASCEMBL trial data, shows Scemblix nearly doubles MMR rates and significantly lowers discontinuation due to adverse reactions compared to Bosulif®.

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Reference News

novartis.com

Novartis receives positive CHMP opinion for Scemblix®, a novel ...

novartis.com

Novartis Scemblix®, with novel mechanism of action, shows superior, ...

Scemblix® (asciminib) demonstrates superior efficacy over Bosulif® (bosutinib) in Ph+ CML-CP patients, with a 37.6% vs. 15.8% major molecular response rate at 96 weeks. It also shows better safety, with lower discontinuation rates due to adverse events (7.7% vs. 26.3%). Scemblix's unique mechanism offers potential to transform CML treatment standards.