Ponatinib plus chemo approved for newly diagnosed Ph+ ALL

This week, FDA granted accelerated approval to ponatinib (Iclusig) with chemotherapy for adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Approval was based on data from the phase 3 PhALLCON trial involving 245 adult patients with newly diagnosed Ph+ ALL. Efficacy was evaluated based on the novel primary endpoint of minimal residual disease (MRD)-negative complete remission (CR) rate at the end of induction.