- sBLA submitted to US FDA for ofatumumab as maintenance therapy in relapsed CLL by Novartis
- Submission based on data from interim results of Phase III PROLONG study
Copenhagen, Denmark; July 22, 2015 — Genmab A/S (OMX: GEN) announced today that a supplemental Biologics License Application (sBLA) has been submitted to the U.S. Food and Drug Administration (FDA) for the use of ofatumumab (Arzerra®) as maintenance therapy of patients with relapsed chronic lymphocytic leukemia (CLL). The application was submitted by Novartis under our ofatumumab collaboration.
The application is based on interim results from a Phase III study, PROLONG (OMB112517) which evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second or third line treatment for CLL. Results from this trial were presented at the 2014 American Society of Hematology Annual Meeting.
“The submission of the application to expand the label to use ofatumumab as a maintenance therapy for patients with relapsed CLL in the U.S. 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,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.