Therapeutic Response

BCR::ABL1 status confers therapeutic sensitivity to Cytarabine in combination with Dexamethasone, Methotrexate, Ponatinib, Prednisone, and Vincristine in patients with Acute Lymphoid Leukemia.

Statements

Source and description
Iclusig (ponatinib) [package insert]. FDA. The U.S. Food and Drug Administration granted accelerated approval to ponatinib in combination with chemotherapy for the treatment of adult patients with newly diagnosed philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The product label notes that this indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction and that continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). This indication is based on PhALLCON (NCT03589326), a randomized, active-controlled, multicenter, open-label trial in which chemotherapy regimens were: vincristine and dexamethasone (induction, cycles 1 to 3); methotrexate and cytarabine (consolidation, cycles 4 to 9, alternating methotrexate and cytarabine); and vincristine and prednisone (maintenance, cycles 10 to 20).
Iclusig (ponatinib) [product information]. EMA. 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).