Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Dasatinib in patients with Acute Lymphoblastic Leukemia.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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. Bristol-Myers Squibb Company. Sprycel (dasatinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021986s021lbl.pdf. Revised December 2018. Accessed October 6, 2026.

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.