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

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, open-label trial. A total of 405 patients were randomized (1:1) to receive either asciminib or