Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized ponatinib in combination with reduced-intensity chemotherapy for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). This approval is based on PhALLCON, a randomized, active controlled, multicenter, open label trial. Patients received the following chemotherapy regimen as part of the study: vincristine and dexamethasone (induction), alternating methotrexate and cytarabine (consolidation), and vincristine and prednisone (maintenance).

This is written in the approval document as:

Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL.

Citation

Incyte Biosciences Distribution B.V. Iclusig (ponatinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf. Revised March 2026. Accessed August 2, 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Contributions