The US Food and Drug Administration (FDA) has approved breakthrough therapy designation for Danish biotechnology company Genmab and British pharmaceutical company GlaxoSmithKline’s (GSK) Arzerra (ofatumumab) in combination with chlorambucil to treat chronic lymphocytic leukemia (CLL) patients, who have not received prior treatment and are inappropriate for fludarabine-based therapy.
The FDA's breakthrough therapy designation for ofatumumab was based on the randomized Phase III clinical trial results in more than 400 patients with previously untreated CLL.
The company announced headline results for the randomized Phase III clinical trial in May 2013 and full study results in December 2013.
GSK biopharmaceutical development vice president and head Dr Kathy Rouan noted this FDA program is intended to expedite not just the development but also the review of drugs for serious or life threatening conditions
"We are actively working on our submission and look forward to the enhanced regulatory interaction allowed for Breakthrough Therapies," Dr Rouan added.
Ofatumumab, a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops, is being developed under a co-development and commercialization agreement between Genmab and GSK.
The breakthrough therapy designation which was enacted as part of the 2012 FDA Safety and Innovation Act includes all the features of the fast track designation, as well as more intensive guidance from the FDA on a drug's clinical development program.
Genmab CEO Dr Jan van de Winkel noted both of Genmab's lead products, ofatumumab and daratumumab, have now been granted breakthrough therapy designations from the FDA.
"This designation for ofatumumab reflects Genmab's mission to create differentiated products aimed at improving the lives of patients suffering from debilitating diseases and for whom existing treatments are inadequate," Dr Winkel added.
