Incyte Corporation (INCY) Release: Jakafi® (ruxolitinib) Product Label Expanded To Include Overall Survival Data And Additional Safety And Dosing Information
7/28/2014 8:49:58 AM
WILMINGTON, Del.--(BUSINESS WIRE)--Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food & Drug Administration (FDA) has approved supplemental labeling for Jakafi® (ruxolitinib) to include new Kaplan-Meier overall survival curves as well as additional safety and dosing information. The new overall survival information is based on three-year data from the two pivotal Phase III trials, COMFORT-I and II, and shows that at three years the probability of survival for patients treated with Jakafi in COMFORT-I was 70% and for those patients originally randomized to placebo it was 61%. In COMFORT-II, at three years the probability of survival for patients treated with Jakafi was 79% and for patients originally randomized to best available therapy (BAT) it was 59%.
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