Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that BCR::ABL1 status confers therapeutic sensitivity to Cytarabine, Dexamethasone, Methotrexate, Ponatinib, Prednisone, Vincristine in patients with Acute Lymphoid Leukemia.
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 statement is based on a regulatory approval from the European Medicines Agency:
Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL.