Safety Study of Fedratinib in Korean Adults with Myelofibrosis Previously Treated with Ruxolitinib

What this Trial Is About

Researchers are evaluating the real-world safety of fedratinib in adults with primary myelofibrosis PMF, post-polycythemia vera myelofibrosis post-PV MF, or post-essential thrombocythemia myelofibrosis post-ET MF who were previously treated with ruxolitinib. This study focuses on patients who have lost adequate response to or are intolerant of ruxolitinib, reflecting the broader patient population with these conditions. The assessment follows approved label and reimbursement criteria from relevant health authorities. Participants will receive fedratinib according to the approved label, reflecting routine clinical use. The study includes all patients treated with fedratinib for up to two years after marketing authorization, with treatment given as prescribed in real-world settings. There are no experimental treatment assignments since this is an observational post-marketing surveillance study. During the study, researchers will monitor participants for adverse events for up to six months to assess the safety of fedratinib in routine practice. Participants will be followed during their clinical care without additional interventions imposed by the study. Data on safety outcomes and treatment use will be collected to better understand fedratinibs profile in this patient population. The study is sponsored by Bristol-Myers Squibb and is expected to continue until late 2027.

A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis