EC Approves Novartis’ Scemblix for Chronic Myeloid Leukemia

The European Commission has approved Novartis’ Scemblix (asciminib) for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

The approval is specifically for patients who have previously been treated with two or more tyrosine kinase inhibitors.

Scemblix is the first and only tyrosine kinase inhibitor that is thought to bind to a different site within the abnormal protein that causes Ph+ CML in chronic phase.

The approval followed a positive opinion by the EMA’s Committee for Medicinal Products for Human Use, based on phase 3 trial results that showed improvements in the molecular response rate.