Incyte Says FDA Updates Prescribing Info for Jakafi

Incyte Corporation

announced today that the U.S. Food and Drug Administration (FDA) has updated prescribing information for Jakafi^® (ruxolitinib) to include new recommended dosing guidance for patients with low platelet counts and additional safety information. Approved in November 2011, Jakafi is the first and only FDA-approved product for the treatment of patients with intermediate or high-risk myelofibrosis. The prescribing information for Jakafi now includes a new recommended starting dose of 5 mg twice daily of Jakafi for patients with baseline platelet counts between 50–100 x 10^9/L (50,000 to 100,000) and the flexibility for subsequent dose modifications based on safety and efficacy. The FDA decision to expand the dosing information followed a review of the supplemental New Drug Application (sNDA), which included data from an ongoing Phase II trial (Study 258) of patients with baseline platelet counts of 50,000 to 100,000. In this trial, the starting dose of 5 mg twice daily could be adjusted up or down based on protocol defined hematology criteria with a target dose of 10 mg twice daily to achieve clinical response. The safety and efficacy findings from the current interim analysis of Study 258 are generally consistent with the results observed in the pivotal, phase III COMFORT-I and COMFORT-II program. “The expanded dosing guidance provides physicians with important new information intended to help patients with low platelet counts experience the clinical benefits of Jakafi, including meaningful spleen reduction and symptom improvement,” stated Paul Friedman, M.D., Incyte's President and Chief Executive Officer. Additionally, new safety information has been added to the Warnings and Precautions section of the prescribing information stating: Progressive multifocal leukoencephalopathy (PML) has been reported with ruxolitinib treatment for myelofibrosis. If PML is suspected, stop Jakafi and evaluate. Language has also been added to the Patient Counseling Information section advising healthcare professionals to inform patients regarding the early signs and symptoms of PML. These changes to the prescribing information are based on one known case of PML with an undetermined relationship to ruxolitinib in the approximately 9,800 myelofibrosis patients treated with ruxolitinib worldwide in clinical trials or with commercial product. There are reports in the medical literature to suggest that patients with myeloproliferative neoplasms, including myelofibrosis, may be at higher risk of developing PML^1-4.