News
CTI BioPharma initiates rolling submission of NDA for pacritinib in myelofibrosis patients with severe thrombocytopenia.
CTI BioPharma Corp. announced that it has commenced a rolling New Drug Application (NDA) submission to the 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 3IIIPERSIST-1 and PERSIST-2, and the Phase II PAC203 trials.
Condition: Myelofibrosis
Type: drug