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Novartis Scemblix® FDA approved in newly diagnosed CML, offering superior efficacy, and favorable safety and tolerability profile

November 01, 2024 8:55 AM | Katy Monaco (Administrator)

Novartis is pleased to announce FDA approval of SCEMBLIX for adults with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).

FDA approval was based on results from ASC4FIRST, a multicenter, randomized, active-controlled, open-label study that evaluated SCEMBLIX vs investigator-selected tyrosine kinase inhibitors (IS-TKIs) (bosutinib, dasatinib, imatinib, nilotinib) in adult patients with newly diagnosed Ph+ CML-CP.

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