Novartis Scemblix Approved In Europe For Adult Patients With Chronic Myeloid Leukemia

Novartis (NVS) said that the European Commission has approved Scemblix (asciminib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase, previously treated with two or more tyrosine kinase inhibitors or TKIs.

The approval was based on results from pivotal Phase III ASCEMBL trial, in which Scemblix (asciminib) nearly doubled the major molecular response rate vs. Bosulif (bosutinib) with a more than three times lower discontinuation rate due to adverse reactions at 24 weeks and confirmed at 96 weeks.

The European Commission approval for Scemblix follows a positive opinion by the Committee for Medicinal Products for Human Use of the European Medicines Agency in June, and the previous designation of Scemblix as an orphan drug; and it is applicable to all 27 European Union member states plus Iceland, Norway and Liechtenstein.

Scemblix has received approval in several countries outside the US, including Japan, Switzerland, and the United Kingdom, for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase with resistance or intolerance to at least two or more previous therapies.

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