NEW YORK – The European Commission on Monday approved Novartis' STAMP inhibitor Scemblix (asciminib) for patients with previously treated Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).
The approval, which is specifically for patients who have received two or more prior tyrosine kinase inhibitors, is based on the results of the Phase III ASCEMBL trial, in which Scemblix improved patients' major molecular response rates compared to Pfizer's Bosulif (bosutinib). After 24 weeks, the major molecular response rates were 25.5 percent among patients treated with Scemblix versus 13.2 percent for patients given Bosulif. Discontinuation due to adverse reactions was also lower with Novartis' drug.
The approval follows in the wake of a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). Scemblix also garnered accelerated approval from the US Food and Drug Administration last fall for Ph+ CML-CP. At the same time, the FDA granted full approval to the agent for Philadelphia chromosome-positive CML patients whose cancers harbor a T315I mutation.