Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized nilotinib for the treatment of pediatric patients with chronic phase Phildelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.

This is written in the approval document as:

Tasigna is indicated for the treatment of paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.

Citation

Novartis Europharm Limited. Tasigna (nilotinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/tasigna-epar-product-information_en.pdf. Revised November 2023. Accessed March 23, 2024.

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+	Nilotinib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2017-11-15	European Medicines Agency	Indication received approval from the European Commission.