Genmab simplified protocol brings ofatumumab filing in lymphoma forward a year
This article was originally published in Scrip
Executive Summary
Genmab has said that regulatory filings for its anti-CD20 monoclonal antibody, ofatumumab, in relapsed or refractory diffuse large B-cell lymphoma (DLBCL) may take place a year earlier than as was anticipated. This follows news that the company has submitted a simplified protocol for its Phase III study of the drug to the US and Europe regulatory authorities which, if approved, could bring forward the primary data read out to early 2014.