Regulatory approval

Published by the European Medicines Agency. Approved

Tasigna is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase.

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)	not BCR::ABL1	Chronic Myelogenous Leukemia	Nilotinib