Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that not BCR::ABL1 status confers therapeutic sensitivity to Imatinib in patients with Acute Lymphoblastic Leukemia.

The European Medicines Agency (EMA) has authorized imatinib as a monotherapy treatment for adult patients with relapased or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

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

Glivec is indicated for the treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy.

Citation

Novartis Europharm Limited. Glivec (imatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/glivec-epar-product-information_en.pdf. Revised November 2023. Accessed March 7, 2024.

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2001-11-07	European Medicines Agency	Indication received approval from the European Commission.