CTI BioPharma, Baxalta Complete Submission of NDA for Pacritinib for Unmet Medical Need In Myelofibrosis

CTI BioPharma Corp.(NASDAQ: CTIC) and Baxalta Incorporated (Baxalta) (NYSE: BXLT) today announced the completion of the rolling submission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. CTI BioPharma and Baxalta are requesting U.S. marketing approval of pacritinib for the treatment of patients with intermediate and high-risk myelofibrosis with low platelet counts of less than 50,000 per microliter (<50,000 μl) – a specific patient population for which there is an existing unmet medical need. the companies are seeking accelerated approval and have requested priority review of application.pacritinib investigational treatment being developed patients with myelofibrosis regardless their platelet counts. if approved, pacritinib would be first jak2 inhibitor indicated baseline counts less <50,000 μl. "we pleased to completed rolling submission look forward working fda during process goal bringing this important people living myelofibrosis, including those low counts," See full press release