FDA approves Novartis' Scemblix for myeloid leukemia

The US Food and Drug Administration has approved Scemblix (asciminib) for the treatment of chronic myeloid leukemia (CML) in two distinct indications, Swiss pharma giant Novartis (NOVN: VX) announced late Friday.

The FDA granted Scemblix accelerated approval for adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors (TKIs), based on major molecular response (MMR) rate at 24 weeks; and full approval for adult patients with Ph+ CML-CP with the T315I mutation.

In accordance with the Accelerated Approval Program, continued approval for the first indication may be contingent upon verification and description of clinical benefit from confirmatory evidence.