Regulatory approval

Published by the European Medicines Agency.

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) previously treated with two or more tyrosine kinase inhibitors.

This is written in the approval document as:

Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP) previously treated with two or more tyrosine kinase inhibitors.

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 January 2024. Accessed March 22, 2024.

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	BCR::ABL1	Chronic Myelogenous Leukemia	Asciminib