Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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 Myelogenous Leukemia Asciminib