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 for the treatment of adult and pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) integrated with chemotherapy.

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

Glivec is indicated for the treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.

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
2013-06-27	European Medicines Agency	Indication received approval from the European Commission.