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.

RELATED: Hematological Disorders Resource Center

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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