Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Bosutinib in patients with Chronic Myeloid Leukemia, BCR-ABL1+.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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. 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 6, 2026.

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.