Pharmaprojects R&D Pipeline News Feed
Double filing for novel antibody therapy
10 Feb 2009
In the space of a week, Genmab, and their partner GlaxoSmithKline, have submitted filings to both the US FDA and the EMEA for their first-in-class anti-CD20 monoclonal antibody, Arzerra (ofatumumab), for the treatment of chronic lymphocytic leukaemia (CLL) in patients refractory to previous therapies. If approved, Arzerra would represent the first anti-CD20 antibody available for this patient population.
The filings are based on data gathered from a Phase III trial in 138 CLL patients treated with single-agent ofatumumab, presented at the 50th Annual Meeting of the American Society of Hematology in December 2008. Overall response rates of 58 and 47% were seen in patients refractory to fludarabine and alemtuzumab treatment, and fludarabine-refractory and alemtuzumab-inappropriate patients, respectively.
There is a need for new CLL treatments, with less than 25% of patients responding to current therapies. As well as representing a promising new hope for these patients, ofatumumab also has the distinction of being the first antibody ever submitted for approval by Genmab.
