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NOVEMBER 8, 2021

FDA Approves Scemblix to Treat Ph-Positive CML in Chronic Phase

Accelerated approval for third-line therapy; full approval for patients with T3151mutation 

The FDA granted accelerated approval for use of asciminib (Scemblix, Novartis) in the treatment of patients with Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) who previously received two or more tyrosine kinase inhibitors (TKIs) as well as full approval for use in adults with Ph+ CML in CP with the T315I mutation.

“CML can be difficult to