Regulatory approval

Published by the Food and Drug Administration.

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 is written in the approval document as:

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)