Regulatory approval

Published by the Health Canada. Approved

Health Canada approved bosutinib for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior TKI therapy.

This is written in the approval document as:

BOSULIF (bosutinib) is indicated for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior TKI therapy.

Citation

Pfizer Canada ULC. Bosulif (bosutinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00082998.PDF. Revised December 2025. Accessed April 2025.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	BCR::ABL1	Chronic Myeloid Leukemia, BCR-ABL1+	Bosutinib

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals