Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Dasatinib in patients with Chronic Myeloid Leukemia, BCR-ABL1+.

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 statement is based on a regulatory approval from the European Medicines Agency:

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.

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.