Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted approval to bosutinib for the treatment of adult and pediatric patients 1 year of age and older with chronic phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy.

This is written in the approval document as:

BOSULIF is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to prior therapy.

Citation

Pfizer, Inc. Bosulif (bosutinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203341s025lbl.pdf. Revised September 2023. Accessed October 30, 2024.

Therapeutic response

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

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

Contributions

Date	Contributor	Description
2025-06-26	Van Allen lab	Resolving statements mapped to incorrect propositions
2024-10-30	Van Allen lab	Initial access of FDA approvals
2023-09-23	Food and Drug Administration	Indication received traditional approval.