Regulatory approval

Published by the European Medicines Agency. Approved

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.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Dasatinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2018-07-02	European Medicines Agency	Indication received approval from the European Commission.