Fedratinib (Inrebic®): A Comprehensive Pharmacological and Clinical Monograph

Section 1: Executive Summary and Drug Profile

Fedratinib is an orally bioavailable, small-molecule kinase inhibitor developed as a targeted therapy for myeloproliferative neoplasms (MPNs).[1] Pharmacologically, it is classified as a potent and selective inhibitor of Janus Associated Kinase 2 (JAK2) and, to a lesser extent, FMS-like tyrosine kinase 3 (FLT3).[3] Its primary, globally approved indication is for the treatment of adult patients with intermediate-2 or high-risk primary myelofibrosis (MF) or secondary myelofibrosis (post-polycythemia vera or post-essential thrombocythemia).[5] The approval of Fedratinib marked a significant development in the therapeutic landscape for this rare and debilitating bone marrow disorder, as it was the second such therapy to receive U.S. Food and Drug Administration (FDA) approval, following a nearly decade-long interval after the approval of ruxolitinib. This addressed a substantial unmet medical need for patients with limited treatment options.[7]