Posted by Michael Wonder on 30 Aug 2022
Novartis Scemblix, with novel mechanism of action, approved by the European Commission for adult patients with chronic myeloid leukaemia
29 August 2022 - Approval based on results from pivotal Phase 3 ASCEMBL trial, in which Scemblix (asciminib) nearly doubled the major molecular response rate versus Bosulif (bosutinib) (25.5% versus 13.2%) with a more than three times lower discontinuation rate due to adverse reactions (5.8% versus 21.1%) at 24 weeks and confirmed at 96 weeks.
Novartis today announced that the European Commission has approved Scemblix (asciminib) for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase, previously treated with two or more tyrosine kinase inhibitors.
