CTI BioPharma Corp. (CTIC) announced the initiation of its rolling new drug application to the U.S. Food and Drug Administration for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R.
As part of the application, CTI and its partner, Baxalta Inc., 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 or <50,000/uL.
If approved for the requested indication, pacritinib would be the first JAK2 inhibitor approved for the treatment of patients with myelofibrosis with platelet counts of less than 50,000/uL, a specific patient population for which there are currently no approved drugs.
The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the FDA on an ongoing basis. CTI BioPharma and Baxalta plan to complete the submission before the end of 2015.
Myelofibrosis is a rare, but serious and life-threatening chronic bone marrow disorder caused by the accumulation of malignant bone marrow cells that triggers an inflammatory response and scars the bone marrow.
Myelofibrosis is associated with significantly reduced quality of life and shortened survival. It can affect patients of all ages, with a median affected age of 65 years, and an estimated prevalence of about 18,000 patients in the U.S.
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