FDA Approves Scemblix for Pretreated CML in the Chronic Phase

The Food and Drug Administration (FDA) granted an accelerated approval to Scemblix (asciminib) for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase (Ph+ CML-CP) who are not tolerant or have had an inadequate response to two or more tyrosine kinase inhibitors (TKIs). The drug was also granted a full approval for adults with Ph+ CML-CP with a T3151 mutation, according to Novartis, the manufacturer of the agent.