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

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Published:4th Feb 2020
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 ┬Ál). 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.>
Condition: Myelofibrosis
Type: drug

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