Regulatory approval

Published by the European Medicines Agency. Approved

Tasigna is indicated for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available.

This is written in the approval document.

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
2007-11-19	European Medicines Agency	Indication received approval from the European Commission.