Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to dasatinib in combination with chemotherapy for the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This indication is based on CA180372 (NCT01460160), a multicenter, multiple-cohort study of pediatric patients with newly diagnosed B-cell precursor Ph+ ALL, where the backbone chemotherapy regimen was AIEOP-BFM ALL 2000 multi-agent chemotherapy protocol.

This is written in the approval document as:

SPRYCEL is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.

Citation

Bristol-Myers Squibb Company. Sprycel (dasatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021986s027lbl.pdf. Revised February 2023. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	BCR::ABL1	Acute Lymphoblastic Leukemia	Dasatinib

Contributions

Date	Contributor	Description
2025-06-26	Van Allen lab	Resolving statements mapped to incorrect propositions
2024-10-30	Van Allen lab	Initial access of FDA approvals
2018-12-21	Food and Drug Administration	Indication received traditional approval.