Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to bosutinib for the treatment of adult patients with accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.

This is written in the approval document as:

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.

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)