Last Updated on December 24, 2023 by The Health Master
Novartis announced that the US Food and Drug Administration (USFDA) approved Scemblix (asciminib) for the treatment of chronic myeloid leukemia (CML) in two distinct indications.
The USFDA granted Scemblix accelerated approval for adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors (TKIs), based on major molecular response (MMR) rate at 24 weeks; and full approval for adult patients with Ph+ CML-CP with the T315I mutation.
In accordance with the Accelerated Approval Program, continued approval for the first indication may be contingent upon verification and description of clinical benefit from confirmatory evidence1.
Scemblix is the first USFDA-approved CML treatment that works by binding to the ABL myristoyl pocket, and represents an important development for patients who experience resistance and/or intolerance to currently available TKI therapies.
Also known as a STAMP inhibitor in scientific literature, Scemblix is being studied across multiple treatment lines for CML-CP, including the ASC4FIRST phase III study evaluating Scemblix as a first-line treatment.
“The introduction of TKIs twenty years ago revolutionized treatment for CML; however, there remain many patients who do not respond adequately to at least two available treatments and often experience challenging side effects that add a burden to their daily lives,” said Lee Greenberger, chief scientific officer at The Leukemia & Lymphoma Society.
“The approval of Scemblix may offer hope to patients by addressing gaps in CML care.”
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