Genmab: FDA Grants Priority Review For Ofatumumab - Quick Facts

(RTTNews) - Genmab A/S (GEN) announced the U.S. FDA has granted Priority Review to the supplemental Biologics License Application, or sBLA, for ofatumumab as maintenance therapy of patients with relapsed chronic lymphocytic leukemia. Genmab said the application was submitted to the FDA by Novartis under the company's ofatumumab collaboration in July 2015. The FDA has given a target date for completion of their review of January 21, 2016.

Ofatumumab, or Arzerra, is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia cells and normal B lymphocytes. Arzerra is marketed under a collaboration agreement between Genmab and Novartis.