Scemblix (asciminib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP).	1
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	ABL1 p.T315I, BCR::ABL1	Chronic Myelogenous Leukemia	Asciminib
EMA (1)	not BCR::ABL1	Chronic Myelogenous Leukemia	Asciminib