FDA approves Scemblix for first-line CML treatment, based on ASC4FIRST trial results.
The FDA has approved Scemblix (asciminib) as a first-line treatment for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase. This decision is based on the ASC4FIRST trial, showing a major molecular response rate of 68% at 48 weeks for Scemblix, compared to 49% for standard tyrosine kinase inhibitors. The approval expands treatment options and may alter the clinical approach to CML.
October 29, 2024
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