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New Phase 3 Data Show Jakafi (ruxolitinib) is Superior to Best Available Therapy in Patients with Polycythemia Vera (PV)

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Additional Relevant Details In RESPONSE-2, patients did not have an enlarged spleen, as assessed by physical examination at each study visit (spleen palpation), and a majority (70%) were previously treated with HU only, therefore considered to have less advanced disease. The remaining patients were treated with multiple lines of therapy (30%).1
“We are pleased with the RESPONSE-2 study results presented at EHA, which reinforce the superiority of Jakafi over best available therapy in achieving hematocrit control, without phlebotomy, in patients with inadequately controlled PV without enlarged spleens,” said Steven Stein, M.D., Incyte’s Chief Medical Officer. “These results are meaningful to patients with uncontrolled PV who have few other treatment options to help manage their disease.”Additionally, the RESPONSE-2 study demonstrated that nearly five times more patients with PV achieved complete hematologic remission with Jakafi compared to BAT at 28 weeks (23.0% vs 5.3% respectively, p=0.0019). Patients taking Jakafi also experienced improvement in their PV symptoms compared to BAT (50% vs 7.7%, respectively). Overall, Jakafi was well tolerated. Findings from this study are consistent with data from the RESPONSE pivotal trial, which evaluated patients with inadequately controlled PV with an enlarged spleen.1,2
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Catalyst Date
Occurred on:
Jun 10, 2016
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Related Keywords Polycythemia Vera, Ruxolitinib, Jakafi