Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized asciminib for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) with the T315I variant who are resistant to, intolerant to, or ineligible for ponatinib.

This is written in the approval document as:

Scemblix is indicated for the treatment of adult patients with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib.

Citation

Novartis Europharm Ltd. Scemblix (asciminib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/scemblix-epar-product-information_en.pdf. Revised July 2026. Accessed August 2, 2026.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	ABL1 p.T315I, BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Asciminib

Contributions

Date	Contributor	Description
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2026-04-23	European Medicines Agency	Indication received approval from the European Commission.