FDA Grants Accelerated Approval for Novartis's Asciminib (Scemblix) for CML, 25% Major Molecular Response Rate

Oct 29, 2024, 05:35 PM

The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Novartis's asciminib (brand name Scemblix) as a treatment for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Clinical trials demonstrated a 25% major molecular response rate at 24 weeks for asciminib, compared to 13% for the previous standard treatment, bosutinib. This approval positions asciminib as a promising option for frontline therapy in this patient population. Further application reviews are ongoing with other regulatory agencies, including Health Canada.