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# CTI BioPharma Myelofibrosis NDA Review Extended
- URL: https://www.fdaweb.com/cti-biopharma-myelofibrosis-nda-review-extended/
- Published: 2021-12-01T12:00:00.000Z
- Updated: 2026-09-14T17:24:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150680

FDA has extended by three months its review of a CTI BioPharma NDA for treating adult patients with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. The new user fee review action target date is 2/28/2022.

“In the course of product labeling discussions, the FDA requested additional clinical data, which was submitted to the agency on 11/24/2021,” the company explains. The agency subsequently determined the submission to be a “major amendment” to the NDA and the user fee date was automatically extended. “At the current time, CTI is not aware of any major deficiencies in the application,” it adds.

Pacritinib is described as a novel oral kinase inhibitor with specificity for JAK2, IRAK1 and CSF1R, without inhibiting JAK1\. The submission was based on data from the Phase 3 PERSIST-2 and PERSIST-1 and the Phase 2 PAC203 clinical trials. “In the PERSIST-2 study, in patients with severe thrombocytopenia who were treated with pacritinib 200 mg twice a day, 29% of patients had a reduction in spleen volume of at least 35%, compared to 3% of patients receiving the best available therapy, which included ruxolitinib; 23% of patients had a reduction in total symptom scores of at least 50%, compared to 13% of patients receiving the best available therapy,” CTI says.