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OCTOBER 31, 2024

FDA Grants Accelerated Approval to Scemblix for Newly Diagnosed Chronic Myeloid Leukemia


Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

The FDA granted accelerated approval to asciminib (Scemblix, Novartis AG) for adult patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).

The efficacy of asciminib for newly diagnosed Ph+ CML in CP was evaluated in ASC4FIRST (ClinicalTrials.gov. Identifier: NCT04971226), a multicenter, randomized, active-controlled,