Incyte announced results from a Phase 3 trial of ruxolitinib compared to best available therapy in patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.
RESPONSE was a global, randomized, open-label trial that included 222 patients with polycythemia vera resistant to or intolerant of hydroxyurea. Patients were randomized 1:1 to receive either ruxolitinib (10mg twice daily) or best available therapy. The dose was adjusted as needed throughout the trial.
The primary endpoint of the trial, the proportion of patients whose hematocrit level is controlled in absence of phlebotomy and whose spleen volume is reduced by ≥35% from baseline as assessed by imaging at 32 weeks was met.
Jakafi (ruxolitinib) is already approved to treat patients with intermediate or high-risk myelofibrosis (MF) including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF.
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