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 for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
This statement is based on a regulatory approval from the Food and Drug Administration:
SPRYCEL is a kinase inhibitor indicated for the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
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/2006/021986lbl.pdf. Revised June 2006. Accessed October 6, 2026.
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2024-10-30 | Van Allen lab | Initial access of FDA approvals |
| 2006-06-28 | Food and Drug Administration | Indication received traditional approval. |