FDA Grants Fast Track Designation to Novel JAK2 Inhibitor for the Treatment of Myelofibrosis

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The U.S. Food and Drug Administration has granted Fast Track designation to pacritinib for the treatment of intermediate- and high-risk myelofibrosis, including patients with disease-related thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose symptoms are suboptimally managed on other JAK2 therapy.

Pacritinib is an oral tyrosine kinase inhibitor with dual activity against JAK2 and FLT3.

Expedited Review

The Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Pacritinib is currently being evaluated in two phase III clinical investigations: the PERSIST-1 trial, which includes a broad set of patients without limitations on blood platelet counts, and the PERSIST-2 trial, which is limited to patients with low platelet counts. ■





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