FDA Grants Accelerated Approval to Iclusig With Chemotherapy for Newly Diagnosed Ph-positive ALL

The FDA granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A.) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

Efficacy was evaluated in PhALLCON (ClinicalTrials.gov Identifier: NCT03589326), a multicenter, randomized, active-controlled, open-label trial of 245 adult patients with newly diagnosed Ph+ ALL. Patients were randomized (2:1) to receive either ponatinib 30 mg orally once daily