Article
FDA Approval Summary: Asciminib for Ph+ CML in Chronic Phase Treated with Two or More Tyrosine Kinase Inhibitors and for the T315I Mutation.
Clinical cancer research : an official journal of the American Association for Cancer Research - 1 Oct 2024
Pamuk Gulsum E, Chow Edwin C Y, Ionan Alexei C, Chen Haiyan, Lee Shwu-Luan, Hsu Vicky, Grimstein Manuela, Zheng Nan, Sun Jielin, Charlab Rosane, Gehrke Brenda J, Vallejo Jonathon, Ehrlich Lori A, de Claro R Angelo, Theoret Marc R
Abstract excerpt
On October 29, 2021, FDA granted accelerated approval to asciminib (SCEMBLIX; Novartis), a tyrosine kinase inhibitor (TKI), for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more TKIs, and granted traditional approval to asciminib for adult patients with Ph+ CML in CP with the T315I mutation. The first...
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