FDA Grants Priority Review for Celgene’s Fedratinib, R2

March 11, 2019

The FDA granted a priority review designation to Celgene’s NDA for fedratinib for the treatment of myelofibrosis, a rare form of chronic leukemia.

Fedratinib is indicated for treatment of newly diagnosed patients and patients who have relapsed or are no longer responding to the current standard treatment, ruxolitinib. The FDA’s decision date on the NDA is Sept. 3, 2019.

The agency has also granted a priority review for Celgene’s supplemental NDA for R2 for the treatment of patients with previously treated follicular and marginal zone lymphoma. The FDA decision date for R2 is June 27, 2019.

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