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.

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