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 U.S. Food and Drug Administration granted approval to dasatinib for the treatment of pediatric patients 1 year of age and older with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

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 Ph+ CML in chronic phase.

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
2024-10-30	Van Allen lab	Initial access of FDA approvals
2018-12-21	Food and Drug Administration	Indication received traditional approval.