News
CTI BioPharma completes rolling submission of NDA for pacritinib in myelofibrosis patients with severe thrombocytopenia.
CTI BioPharma Corp. announced that it has completed 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 had previously announced the results of a pre-NDA meeting with FDA where agreement was reached on an NDA submission package based upon available data from the completed Phase III PERSIST-1 and PERSIST-2 trials and the Phase II PAC203 trials.
Condition: Myelofibrosis
Type: drug
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