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March 7, 2014
05:37 EDTINCYIncyte announces Phase III study of ruxolitinib meets primary endpoint
Incyte announced that a pivotal Phase III trial of ruxolitinib compared to best available therapy in patients with polycythemia vera who are resistant to or intolerant of hydroxyurea has met its primary endpoint of achieving phlebotomy independence and reducing spleen size by 35% or more. The safety profile of ruxolitinib was generally consistent with previous studies based on initial review of the data. Ruxolitinib, marketed as Jakafi in the United States, is approved to treat people with intermediate or high-risk myelofibrosis, or MF, including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF. The global, randomized, open-label Phase III trial, called RESPONSE, was conducted at 109 sites. The trial included 222 patients with polycythemia vera resistant to or intolerant of hydroxyurea. Patients were randomized 1:1 to receive either ruxolitinib or best available therapy. The dose was adjusted as needed throughout the trial. The primary endpoint of the trial is the proportion of patients whose hematocrit level is controlled in absence of phlebotomy and whose spleen volume is reduced by 35 percent or more from baseline as assessed by imaging at 32 weeks. In addition to safety, key secondary endpoints include durable response and complete hematological remission. Data from RESPONSE are expected to be presented at an upcoming scientific meeting and submitted to the FDA this year.
News For INCY From The Last 14 Days
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November 20, 2014
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13:26 EDTINCYLeerink biotech analysts hold an analyst/industry conference call
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November 12, 2014
11:17 EDTINCYLeerink major pharma & biotech analysts hold analyst/industry conference call
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November 11, 2014
16:14 EDTINCYLeerink biotech analysts hold an analyst/industry conference call
Biotech Analysts provide a preview of items being discussed at the upcoming 56th Annual Meeting of ASH including JAK inhibitors, novel Jakafi combinations for Myelofibrosis and developing compounds on an Analyst/Industry conference call to be held on November 17 at 10 am.
15:43 EDTINCYLeerink major pharma & biotech analysts hold analyst/industry conference call
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