19 September 2015 - Genmab announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for ofatumumab acetate (Arzerra) as maintenance therapy of patients with relapsed chronic lymphocytic leukemia (CLL). The application was submitted to the FDA by Novartis under our ofatumumab collaboration in July 2015.

Priority Review is an FDA designation for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy. The FDA aims to complete its review of the ofatumumab sBLA within the time set by the Prescription Drug User Fee Act (PDUFA) and has given a target date for completion of their review of January 21, 2016.

"We are very pleased that the FDA has granted Priority Review for ofatumumab, which means ofatumumab could potentially be available as a maintenance therapy for patients suffering from relapsed CLL relatively soon," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to receiving FDA's feedback on the application."

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.

For more details, go to: http://ir.genmab.com/releasedetail.cfm?ReleaseID=932308