Genmab and Novartis submit supplemental BLA to FDA for Arzerra

Danish biotech company Genmab has submitted a supplemental Biologics License Application to the US Food and Drug Administration for Arzerra (ofatumumab) as a maintenance therapy of patients with relapsed chronic lymphocytic leukemia.

The application was submitted by Novartis (VTX: NOVN) under its collaboration with Genmab, and is based on interim results from a Phase III study evaluating ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second or third line treatment for the indication.

Jan van de Winkel, chief executive of Genmab, said: “The submission of the application to expand the label to use ofatumumab as a maintenance therapy for patients with relapsed CLL in the US follows closely behind the marketing application for this indication in Europe. We are looking forward to the response from both the U.S. and European regulatory authorities, and hope that ofatumumab will soon become available for maintenance therapy of patients with relapsed CLL.”