Regulatory approval
Published by the Food and Drug Administration.
The U.S. Food and Drug Administration granted approval to dasatinib for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
This is written in the approval document as:
SPRYCEL is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (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.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | BCR::ABL1 | Chronic Myelogenous Leukemia | Dasatinib | |
| Sensitivity (+) | BCR::ABL1 | Chronic Myeloid Leukemia, BCR-ABL1+ | Dasatinib | |
| Sensitivity (+) | BCR::ABL1 | Chronic Myelogenous Leukemia | Dasatinib | |
| Sensitivity (+) | BCR::ABL1 | Chronic Myeloid Leukemia, BCR-ABL1+ | Dasatinib | |
| Sensitivity (+) | BCR::ABL1 | Chronic Myelogenous Leukemia | Dasatinib | |
| Sensitivity (+) | BCR::ABL1 | Chronic Myeloid Leukemia, BCR-ABL1+ | Dasatinib |