CTI has reached agreement with the FDA on an accelerated approval pathway for pacritinib for the treatment of myelofibrosis patients with severe thrombocytopenia.

CTI BioPharma announced that following a meeting with the FDA, CTI has reached agreement on an accelerated approval pathway for pacritinib for the treatment of myelofibrosis patients with severe thrombocytopenia (platelet counts <50,000 l. cti will be amending the pacifica pivotal phase iii trial protocol to allow for the primary analysis of svr rates on the first 168 patients with an end-of-study analysis of tss and os following the full enrollment of 348 patients.>

If the primary endpoint of SVR is met following the planned review of data from the first 168 patients, CTI intends to submit a New Drug Application (NDA) under the FDA's subpart H regulations, subject to review of all available efficacy and safety data. Conversion to a regular approval of pacritinib would be anticipated following the successful end-of-study assessment of the secondary efficacy endpoints, and the completion of post-marketing requirements.