- CTI BioPharma (NASDAQ:CTIC) begins its rolling submission of its New Drug Application (NDA) for lead product candidate and Fast Track-tagged pacritinib for the treatment of patients with intermediate and high risk myelofibrosis with low platelet counts (<50K/uL). If approved, pacritinib will be the first drug approved for the indication and the first JAK2 inhibitor. The submission should be completed by year end.
- CTI is co-developing pacritinib with Baxalta (BXLT). The companies will jointly commercialize the product in the U.S. while Baxalta has exclusive commercialization rights ex-U.S.
- Myelofibrosis is a rare, serious and life-threatening chronic bone marrow disorder caused by the accumulation of malignant bone marrow cells that trigger an inflammatory response that scars the bone marrow. It strikes ~18K Americans each year.
- Previously: CTI BioPharma up 18% on positive results for pacritinib in rare blood cancer (June 1)
- Previously: FDA Fast Tracks CTI blood cancer drug (Aug. 7, 2014)