Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized nilotinib for the treatment of adult patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy including imatinib. Nilotinib's product information further states that efficacy data in patients with CML in blast crisis are not available.

This is written in the approval document as:

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.

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.

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