Sprycel (dasatinib [anhydrous]) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
SPRYCEL is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) in the chronic phase.	1
SPRYCEL is indicated for the treatment of adult patients with Ph+ acute lymphoblastic leukaemia (ALL) and lymphoid blast CML with resistance or intolerance to prior therapy.	2
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.	1
SPRYCEL is indicated for the treatment of paediatric patients with newly diagnosed Ph+ ALL in combination with chemotherapy.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (3)	BCR::ABL1	Chronic Myelogenous Leukemia	Dasatinib
EMA (2)	BCR::ABL1	Acute Lymphoid Leukemia	Dasatinib