A Randomized, Phase 3 Trial of Fedratinib Versus Best Available Therapy in Patients with Intermediate-2 or High-Risk Myelofibrosis Previously Treated with Ruxolitinib (FREEDOM2) (original) (raw)

Blood, 2021

Abstract

Background: Until recently, ruxolitinib (RUX) was the only drug approved for treatment of intermediate- or high-risk myelofibrosis (MF). Many patients discontinue RUX due to lack of response, loss of efficacy, or intolerance. Fedratinib (INREBIC) is an oral, selective kinase inhibitor with activity against mutant and wild-type JAK2 and FLT3. Fedratinib is approved in the United States, Canada, European Union, United Kingdom, and elsewhere as front-line therapy for treatment of patients with JAK-inhibitor-naïve MF and those previously treated with RUX. In the single-arm, phase 2 JAKARTA2 trial of fedratinib 400 mg/day (starting dose) in patients with MF relapsed, refractory, or intolerant to prior RUX, 31% of pts achieved a spleen volume response and 27% achieved a symptom response with fedratinib (Harrison, Am J Hematol 2020). Gastrointestinal (GI) events were among the most common adverse events (AEs) reported during fedratinib treatment in JAKARTA2. A clinical hold was placed on f...

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