CHMP Issues Positive Opinion for Ofatumumab Combo in Relapsed CLL

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of ofatumumab in combination with fludarabine and cyclophosphamide as a treatment for patients with relapsed chronic lymphocytic leukemia (CLL), according to Genmab, which codevelops the anti-CD20 antibody with Novartis.The application for ofatumumab was based on data from the phase III COMPLEMENT-2 study, in which the median progression-free survival … Leggi tutto