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FDA Grants Fedratinib Priority Review for Myelofibrosis

Gina Columbus @ginacolumbusonc
Published: Tuesday, Mar 05, 2019

The FDA has granted a priority review designation to a new drug application (NDA) for fedratinib as a treatment for patients with myelofibrosis.



  1. U.S. FDA Grants Priority Review for Fedratinib New Drug Application in Myelofibrosis. Celgene. Published March 5, 2019. Accessed March 5, 2019.
  2. Pardanani A, Harrison C, Cortes JE, et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: a randomized clinical trial. JAMA Oncol. 2015;1(5):643-651. doi: 10.1001/jamaoncol.2015.1590.
  3. Harrison CN, Schaap N, Vannucchi AM, et al. Janus kinase-2 inhibitor fedratinib in patients with myelofibrosis previously treated with ruxolitinib (JAKARTA-2): a single-arm, open-label, non-randomised, phase 2, multicentre study. Lancet Haematology. 2017;4(7):PE317-E324. doi: 10.1016/S2352-3026(17)30088-1.

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