Fedratinib: First Approval

Compliance with Ethical Standards

Funding The preparation of this review was not supported by any external funding.

Conflicts of interest During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Hannah A. Blair is a salaried employee of Adis International Ltd/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.

Additional information about this Adis Drug Review can be found here.

Abstract

Fedratinib (INREBIC^®) is a JAK2-selective inhibitor that has been developed as an oral treatment for myelofibrosis. In August 2019, fedratinib received its first global approval in the USA for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. Phase III clinical development for myelofibrosis is ongoing worldwide. This article summarizes the milestones in the development of fedratinib leading to this first approval for myelofibrosis.

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