CTI BioPharma Initiates Rolling Submission of U.S. NDA for Pacritinib for Treatment of Patients with Myelofibrosis

CTI BioPharma Corp. (NASDAQ: CTIC) announced the initiation of its rolling 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. As part of the application, CTI BioPharma and its partner, Baxalta Incorporated (Baxalta), are seeking accelerated approval and priority review for 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 ul). if approved for the requested indication, pacritinib would be first jak2 inhibitor treatment of patients with myelofibrosis platelet counts less than 50,000 ul – a specific patient population which there are currently no drugs. rolling nda allows completed portions an to submitted and reviewed by fda on ongoing basis. cti biopharma baxalta plan complete submission before end 2015.myelofibrosis (a type myeloproliferative neoplasm) is rare, but serious life-threatening chronic bone marrow disorder caused accumulation malignant See full press release