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A phase 3, multicenter, open-label, randomized study to evaluate the efficacy and safety of fedratinib compared to best available therapy (BAT) in subjects with DIPSS (dynamic international prognostic scoring system)-intermediate or high-risk primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (post-PV MF), or post-essential thrombocythemia myelofibrosis (post-ET MF) and previously treated with ruxolitinib. NCT03952039.

Al-Ali HK et al. Safety and efficacy of ruxolitinib in an open-label, multicenter, single-arm phase 3b expanded-access study in patients with myelofibrosis: A snapshot of 1144 patients in the JUMP trial. Haematologica 2016;101(9):1065-73. Abstract

Bose P, Verstovsek S. Management of myelofibrosis after ruxolitinib failure. Leuk Lymphoma 2020;61(8):1797-809. Abstract

Cervantes F et al. Safety and efficacy of ruxolitinib (rux) in patients with myelofibrosis (mf) and anemia (HB < 10 g/dl): Results at week (wk) 24 of the REALISE trial. EHA 2019;Abstract PS1465.

Harrison CN et al. Fedratinib in patients with myelofibrosis previously treated with ruxolitinib: An updated analysis of the JAKARTA2 study using stringent criteria for ruxolitinib failure. Am J Hematol 2020;95(6):594-603. Abstract

Harrison C et al. JAK inhibition with ruxolitinib versus best available therapy for myelofibrosis. N Engl J Med 2012;366(9):787-98. Abstract

Kiladjian JJ et al. Long-term efficacy and safety of ruxolitinib versus best available therapy in polycythaemia vera (RESPONSE): 5-year follow up of a phase 3 study. Lancet Hematology 2020;7(3):e226-37. Abstract

Mead AJ et al. Response to ruxolitinib in patients with intermediate-1-, intermediate-2-, and high-risk myelofibrosis: Results of the UK ROBUST Trial. Br J Haematol 2015;170(1):29-39. Abstract

Palandri F et al. Efficacy and safety of ruxolitinib in intermediate-1 IPSS risk myelofibrosis patients: Results from an independent study. Hematol Oncol 2018;36(1):285-90. Abstract

Pardanani A et al. Safety and efficacy of fedratinib in patients with primary or secondary myelofibrosis: A randomized clinical trial. JAMA Oncol 2015;1(5):643-51. Abstract

Vannucchi AM et al. A pooled analysis of overall survival in COMFORT-I and COMFORT-II, 2 randomized phase III trials of ruxolitinib for the treatment of myelofibrosis. Haematologica 2015;100(9):1139-45. Abstract

Verstovsek S et al. Real-world survival in elderly patients with myelofibrosis in the United States: Ruxolitinib exposed vs unexposed. EHA 2020;Abstract EP1124.

Verstovsek S et al. Ruxolitinib for essential thrombocythemia refractory to or intolerant of hydroxyurea: Long-term phase 2 study results. Blood 2017;130(15):1768-71. Abstract

Verstovsek S et al. Efficacy, safety, and survival with ruxolitinib in patients with myelofibrosis: Results of a median 3-year follow-up of COMFORT-I. Haematologica 2015;100(4):479-88. Abstract

Verstovsek S et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med 2012;366(9):799-807. Abstract