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EMA's CHMP Recommends Novartis' Scemblix for TKI-Intolerant Chronic Myeloid Leukemia Patients

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended Novartis' Scemblix (asciminib) for previously treated Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

The recommendation is specifically for patients who have previously received two or more tyrosine kinase inhibitors. The committee based its decision on the results of the Phase III ASCEMBL trial. After 24 weeks on treatment, 25.5 percent of patients treated with Scemblix had a major molecular response versus 13.2 percent of patients treated with the comparator drug, Pfizer's Bosulif (bosutinib). After 96 weeks, these major molecular response rates were 37.6 percent and 15.8 percent for patients on Scemblix and Bosulif, respectively.

If the EMA follows CHMP's recommendation and approves Scemblix for this CML patient population, the drug will be the first STAMP inhibitor approved in this setting in Europe.

Last fall, the US Food and Drug Administration granted accelerated approval to Scemblix for the same indication while also granting full approval to the agent for patients with Philadelphia chromosome-positive CML in the chronic phase whose cancers harbor the T315I mutation.