Priority Review granted for CLL combination therapy
COPENHAGEN, Denmark—The U.S. Food and Drug Administration (FDA) has granted priority review to the supplemental Biologics License Application for the use of ofatumumab in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL), Genmab A/S reported recently. Novartis submitted the application this March under its ofatumumab collaboration with Genmab, and the FDA intends to complete its review in six months, with a Prescription Drug User Fee Act target action date of Sept. 10. The application was based on the results of the Phase 3 COMPLEMENT 2 study, which evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL. The study saw a median progression-free survival—the primary endpoint—in patients receiving the combination treatment of 28.9 months, compared to 18.8 months in patients only receiving FC.