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 acute lymphoblastic leukemia (ALL) in combination with chemotherapy. The product information for this indication further states that his indication is based on a multicenter, historically-controlled phase 2 study that followed the chemotherapy regime detailed in another clinical trial, AIEOP-BFM ALL 2000 (chemotherapeutic standard multi-agent chemotherapy protocol).

This is written in the approval document as:

SPRYCEL is indicated for the treatment of paediatric patients with newly diagnosed Ph+ ALL in combination with chemotherapy.

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	Acute Lymphoid Leukemia	Dasatinib