Incyte has announced that the 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 survival information is based on three-year data from two pivotal Phase 3 trials, COMFORT-I and –II. This information shows that at three years, the probability of survival for patients treated with Jakafi in COMFORT-I was 70% and 61% for those patients originally randomized to placebo. In COMFORT-II, at three years the probability of survival for patients treated with Jakafi was 79% and 59% for patients originally randomized to best available therapy.
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The new product label also includes information regarding the risk and management of tuberculosis, modified information regarding symptom exacerbation following interruption and discontinuation of Jakafi, and modified dosing guidelines regarding concomitant use with CYP3A4 inhibitors and fluconazole.
Jakafi is approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.
For more information call (822) 463-3463 or visit Incyte.com.