Therapeutic Response

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