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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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July 31, 2014
13:39 EDTINCYIncyte reported strong Q2 results, says Leerink
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13:18 EDTINCYIncyte shares defended at UBS
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12:52 EDTINCYIncyte weakness a buying opportunity, says Brean Capital
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07:22 EDTINCYIncyte raises FY14 Jakafi net product revenue view to $330M-$340M
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07:15 EDTINCYIncyte reports Q2 EPS (22c), may not compare to consensus (4c)
Reports Q2 revenue $99.6M, consensus $127.19M.
July 30, 2014
08:32 EDTINCYIncyte announces clinical trial agreement with Genentech
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July 28, 2014
07:02 EDTINCYIncyte says FDA approves supplemental labeling for Jakafi
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July 24, 2014
06:57 EDTINCYIncyte trial miss does not impact Jakafi assumptions, says Leerink
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July 23, 2014
16:41 EDTINCYIncyte's Ruxolitinib shows no statistical significance in primary endpoint
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