Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized dasatinib (anhydrous) for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in the chronic phase (Ph+ CML-CP) or Ph+CML-CP with resistant or intolerant to prior therapy including imatinib.

This is written in the approval document as:

SPRYCEL is indicated for the treatment of paediatric patients with newly diagnosed Ph+ CML in chronic phase (Ph+ CML-CP) or Ph+ CML-CP resistant or intolerant to prior therapy including imatinib.

Citation

Bristol-Myers Squibb Pharma EEIG. Sprycel (dasatinib [anhydrous]) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/sprycel-epar-product-information_en.pdf. Revised June 2022. 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	Dasatinib