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# FDA Approves Novartis’ Scemblix for Some Leukemias
- URL: https://www.fdaweb.com/fda-approves-novartis-scemblix-for-some-leukemias/
- Published: 2021-11-02T12:00:00.000Z
- Updated: 2026-09-14T17:21:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150496

FDA has approved Novartis’ Scemblix (asciminib) for treating chronic myeloid leukemia (CML) in two distinct indications. The company [says](https://www.marketwatch.com/press-release/fda-approves-novartis-scemblix-asciminib-with-novel-mechanism-of-action-for-the-treatment-of-chronic-myeloid-leukemia-2021-11-01?tesla=y&ref=fdaweb.com) it received accelerated approval for adult patients with Philadelphia chromosome-positive CML in chronic phase previously treated with two or more tyrosine kinase inhibitors (TKIs), based on major molecular response rate at 24 weeks. And it was granted full approval for adult patients with Philadelphia chromosome-positive CML in chronic phase with the T3151 mutation.

Novartis says Scemblix is the first FDA-approved CML treatment that works by binding to the ABL myristoyl pocket. It is said to be an important development for patients who experience resistance and/or intolerance to currently available TKI therapies.