Posted by Michael Wonder on 14 Oct 2020
CTI BioPharma initiates rolling submission of new drug application for pacritinib in myelofibrosis patients with severe thrombocytopenia
13 October 2020 - Completion of submission expected in first quarter 2021.
CTI BioPharma today announced that it has commenced a rolling new drug application submission to the U.S. FDA seeking approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet counts less than 50 x 109/L).
CTI has previously announced the results of a recent Pre-NDA meeting with FDA where agreement was reached on an NDA submission package based upon available data from the completed Phase 3 PERSIST-1 and PERSIST-2, and the Phase 2 PAC203 trials.
