Benzinga | Oct 13, 2020 07:01AM EDT

CTI BioPharma Initiates Rolling Submission Of New Drug Application (NDA) For Pacritinib In Myelofibrosis Patients With Severe Thrombocytopenia

- Completion of Submission Expected in First Quarter 2021 -

- Pre-Commercialization Activities are Underway -

SEATTLE, Oct. 13, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced that it has commenced a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration ("FDA" or "the Agency") 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.

"Today we are pleased to announce the start of a rolling NDA submission that seeks to address the important unmet medical need of myelofibrosis patients with severe thrombocytopenia, a population that includes both front-line treatment-na?ve patients and patients with prior exposure to JAK2 inhibitors," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "We have started pre-commercial activities and are planning for a commercial launch in 2021, subject to priority review."