Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to asciminib for the treatment of adult patients with philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) with the T315I mutation.

This is written in the approval document as:

SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with Ph+ CML in CP with the T315I mutation.

Citation

Novartis Pharmaceuticals Corporation. Scemblix (asciminib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf. Revised October 2024. Accessed January 10, 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ABL1 p.T315I, BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Asciminib

Contributions

Date	Contributor	Description
2025-01-10	Van Allen lab	Additional FDA approvals for initial version
2021-10-29	Food and Drug Administration	Indication received traditional approval.