Benzinga | Mar 31, 2021 07:13AM EDT

CTI BioPharma Announces Completion of Rolling Submission of New Drug Application for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia

CTI BioPharma Corp. (NASDAQ:CTIC) today announced that it has completed a rolling New Drug Application ("NDA") submission to the U.S. Food and Drug Administration ("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 3 PERSIST-1 and PERSIST-2 trials and the Phase 2 PAC203 trials.

"The completion of the pacritinib NDA submission is the result of many years of clinical research and a collaborative and constructive dialogue with the FDA on how pacritinib could address the unmet medical need of myelofibrosis ("MF") patients with severe thrombocytopenia. MF patients with severe thrombocytopenia experience poor treatment outcomes, primarily due to their severely cytopenic disease and the significant limitations of approved therapies," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "CTI has initiated pre-commercialization activities and has completed the hiring of a commercial leadership team. Assuming a successful priority review of the NDA, we are preparing for a commercial launch of pacritinib before the end of 2021. We look forward to providing updates on the NDA and our commercialization plans over the coming months."