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Ofatumumab treatment accepted for priority review by FDA


Genmab has announced that the U.S. Food and Drug Administration (FDA) granted Priority Review to the  supplemental Biologics License Application (sBLA) for the use of ofatumumab (Arzerra) in combination with  fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL).

The application was submitted to the FDA by Novartis in March 2016 under the ofatumumab collaboration between Novartis and Genmab.

Priority Review is an FDA designation for drugs that treat serious conditions and which may provide a significant improvement in safety or efficacy compared to existing standard therapies.  The FDA aims to complete its review of the ofatumumab sBLA within six months and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 10, 2016

“With the FDA’s acceptance of this sBLA, ofatumumab is one step closer to potentially benefiting an even wider population of patients than it is currently,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We look forward to the FDA’s feedback on this application.”

The application was based on results from a Phase III study, COMPLEMENT 2, which evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL.  Top-line results from this trial were reported in April 2015.