Novartis: positive opinion for Scemblix in CML

(CercleFinance.com) - Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for Scemblix, a new treatment for adult patients with chronic myeloid leukemia (CML).


The CHMP recommends a marketing authorisation in Europe for adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+-PC CML), previously treated with two or more tyrosine kinase inhibitors (TKIs).

This opinion is based on the pivotal phase III ASCEMBL trial, which showed a near doubling of the major molecular response rate and a more than three-fold lower drop-out rate for adverse events with Scemblix compared to Bosulif at 24 weeks.


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