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FDA Approves Novartis Scemblix® for Newly Diagnosed CML, Showcasing Superior Efficacy and Improved Safety Profile

NextEdge Admin

30 Oct 2024

2 min 42 sec

Novartis announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Scemblix® (asciminib) as a first-line treatment for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). The approval is based on data from the ASC4FIRST Phase III trial, which demonstrated superior efficacy of Scemblix compared to investigator-selected (IS) standard-of-care (SoC) tyrosine kinase inhibitors (TKIs), including imatinib, nilotinib, dasatinib, and bosutinib.

The trial showed that nearly 20% more patients achieved major molecular response (MMR) at week 48 with Scemblix (68% vs. 49%) compared to IS-TKIs and almost 30% more (69% vs. 40%) versus imatinib alone. Scemblix also demonstrated improved tolerability, with fewer severe adverse reactions (25.5% vs. 33–42%), lower dose reduction rates (6% vs. 14–24%), and half the treatment discontinuation rate (4.5% vs. 9.8–11%).

“Many newly diagnosed CML patients struggle with side effects that lead them to stop or switch treatments,” said Lee Greenberger, Ph.D., Chief Scientific Officer, The Leukemia & Lymphoma Society. “Access to an effective, well-tolerated option from the start can improve long-term disease control.”

Jorge Cortes, M.D., Director, Georgia Cancer Center, highlighted Scemblix as the first therapy to achieve strong outcomes across efficacy, safety, and tolerability compared to other TKIs, calling the results “potentially practice-changing.”

With this expanded indication, Scemblix becomes available to a much larger patient population, offering a new treatment option that redefines the standard of care in CML. The ASC4FIRST trial will continue through week 96 to assess additional outcomes. Novartis reaffirmed its commitment to innovation in CML, supporting patients with a treatment that offers both superior efficacy and better tolerability.