Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to dasatinib for the treatment of adult patients with chronic, accelerated, or myeloid or lymphoid blast phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib.

This is written in the approval document as:

SPRYCEL is a kinase inhibitor indicated for the treatment of adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.

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.

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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