Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Imatinib in patients with Acute Lymphoid 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.