FDA accepts filing of sNDA for Jakafi for treatment of Polycythemia Vera - Incyte/Novartis

The FDA has accepted for filing the supplemental New Drug Application (sNDA) for ruxolitinib from Incyte as a potential treatment of patients with Polycythemia Vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. The sNDA includes results from the RESPONSE Phase III trial, which were recently presented at the 2014 American Society of Clinical Oncology (ASCO) annual meeting. RESPONSE was conducted under a Special Protocol Assessment (SPA) from the FDA.