Regulatory approval

Published by the Food and Drug Administration. Approved

SPRYCEL is a kinase inhibitor indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase.

This is written in the approval document.

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.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (2) BCR::ABL1 Chronic Myeloid Leukemia, BCR-ABL1+ Dasatinib

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.