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 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.