Regulatory approval

Published by the European Medicines Agency. Approved

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).

This is written in the approval document.

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.

Therapeutic response

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

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

Contributions

Date	Contributor	Description
2025-08-29	Van Allen lab	On 2025-08-26, the EMA published an EPAR - Assessment report - Variation that revised indications for Bosulif (bosutinib) to support pediatric patients with chronic phase Ph+ CML.
2025-06-02	European Medicines Agency	Indication received approval from the European Commission.
2024-10-20	Van Allen lab	Adding EMA approvals for use to database