FDA Approves Novartis’ Scemblix for Chronic Myeloid Leukemia Patients

The FDA has granted Novartis’ Scemblix (asciminib) accelerated approval for treating chronic myeloid leukemia (CML) in adults with a specific chronic form of the disease.

The accelerated approval is indicated only for patients with the Philadelphia chromosome-positive (Ph+) form of CML who have been previously treated with two or more tyrosine kinase inhibitors (TKIs).

In addition, the agency granted Scemblix a full approval for Ph+ CML patients in chronic phase with the T3151 mutation, a genetic change in cancer cells which can stop TKIs from working.

The approvals were supported by positive phase 1 and phase 3 data in which Scemblix (asciminib) showed superiority in patients’ major molecular response rate when compared against Pfizer’s Bosulif (bosutinib).