FDA Grants Fedratinib Priority Review for Myelofibrosis

March 5, 2019 – The FDA has granted a priority review designation to a new drug application (NDA) for fedratinib as a treatment for patients with myelofibrosis. The designation is based on results from the phase III JAKARTA2 and phase II JAKARTA-2 trials3, which evaluated fedratinib in patients with primary or secondary myelofibrosis, and in those patients who were previously exposed to ruxolitinib, respectively. Results of both studies demonstrated a … (leggi tutto)