Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized bosutinib as for the treatment of adult and pediatric patients aged 6 years and older with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML).

This is written in the approval document as:

Bosulif is indicated for the treatment of adult and paediatric patients aged 6 years and older with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML).

Citation

Pfizer Europe MA EEIG. Bosulif (bosutinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/bosulif-epar-product-information_en.pdf. Revised August 2025. Accessed August 29, 2025.

View API

Therapeutic response

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

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) BCR::ABL1 Chronic Myelogenous Leukemia Bosutinib
Sensitivity (+) BCR::ABL1 Chronic Myelogenous Leukemia Bosutinib