Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Nilotinib in patients with Chronic Myeloid Leukemia, BCR-ABL1+.

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 statement is based on a regulatory approval from the European Medicines Agency:

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.

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.