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Fedratinib Re-emerges as FDA-Approved Treatment of Myelofibrosis

Andrew Kuykendall, MD
Published Online:2:53 PM, Thu October 17, 2019


Andrew Kuykendall, MD, assistant member at the Moffitt Cancer Center, discusses the background to the JAK2 inhibitor fedratinib (Inrebic), which was approved by the FDA in August 2019 for the treatment of patients with intermediate-2 or high-risk primary or secondary myelofibrosis (MF), including post–polycythemia vera or post–essential thrombocythemia MF.

Kuykendall says fedratinib has an interesting story. It’s a relatively old drug that had previously been through extensive clinical trials years ago and has now re-emerged. He calls this a rising-from-the-ashes story to describe the evolution of fedratinib and its move toward the treatment landscape for patients with MF.

Investigators had concerns about safety after going through phase III clinical trials with patients who had received prior ruxolitinib (Jakafi) treatment due to potential cases of Wernicke’s encephalopathy, and so the drug was put on hold. After analysis of these safety signals, in which few cases were true Wernicke’s encephalopathy, investigators took another look at the efficacy. This re-analysis led to its approval for the treatment of patients with MF, says Kuykendall. The addition of this agent to the treatment paradigm is an exciting and promising change for the treatment of these patients.
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