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Novartis' Scemblix Gets Positive CHMP Opinion For Treatment Of Chronic Myeloid Leukemia

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting marketing authorization for Scemblix or asciminib for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), previously treated with two or more tyrosine kinase inhibitors, Novartis (NVS) said in a statement on Friday.

The positive opinion was based on data from pivotal Phase III ASCEMBL trial, showing a near doubling in major molecular response rate for patients treated with Scemblix (asciminib) vs. Bosulif (bosutinib) (25.5% vs. 13.2%) and more than three times lower discontinuation rate due to adverse reactions (5.8% vs 21.1%) at 24 weeks.

The CHMP recommended approval of Scemblix in CML will be referred to the European Commission. The EC will review the CHMP recommendations and deliver a final decision in the coming months.

The CHMP recommendation comes after the approval of Scemblix by the U.S. FDA and other countries' regulatory authorities, potentially broadening access for more patients to Novartis transformative therapies in CML.

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