Bosulif (bosutinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1
BOSULIF is a kinase inhibitor indicated for the treatment of adult patients with accelerated, or blast phase Ph+ CML with resistance or intolerance to prior therapy.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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