CTI withdraws MAA for myleofibrosis therapy

CTI BioPharma Corp. (NASDAQ:CTIC) withdrew its MAA for pacritinib to treat myelofibrosis following interactions with EMA's CHMP suggesting the committee was likely to issue a negative opinion. CTI said CHMP indicated the risk-benefit profile of the therapy in the indication had not been sufficiently established by clinical data.

The company plans to start a Phase III trial of the orally available dual inhibitor of JAK-2 and FLT3 to treat myelofibrosis in patients with severe thrombocytopenia in 3Q19. CTI said it plans to meet with EMA for guidance before initiating the trial and has discussed trial design with FDA...