Iclusig Accelerated Approval for Leukemia

FDA has granted Takeda Pharmaceutical accelerated approval for Iclusig (ponatinib) for use with chemotherapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

The approval was based on data from the PhALLCON (NCT03589326) study of 245 adult patients with newly diagnosed Ph+ ALL. Efficacy was based on the minimal residual disease-negative complete remission rate at the end of induction, which was 30% in the ponatinib arm compared with 12% in the imatinib arm (an unapproved regimen), according to an FDA release.

The agency says the most common adverse reactions observed in the study were hepatic dysfunction, arthralgia, rash and related conditions, headache, pyrexia, abdominal pain, constipation, fatigue, nausea, oral mucositis, hypertension, pancreatitis/elevated lipase, peripheral neuropathy, hemorrhage, febrile neutropenia, fluid retention and edema, vomiting, paresthesia, and cardiac arrhythmias.