Genmab will not file Arzerra for NHL after Phase III trial failure
This article was originally published in Scrip
Genmab will not file its lead drug candidate, the anti-CD20 monoclonal antibody drug Arzerra (ofatumumab), for what would have been its biggest indication to date – refractory follicular non-Hodgkin’s lymphoma (NHL) – after the pivotal Phase III trial in this population failed to meet its primary response rate endpoint. The result also led the company to cut its 2009 revenue forecast and to a 30% fall in its share price on August 18th.
You may also be interested in...
The development of drugs to prevent cancer has lagged far behind the development of drugs, such as the statins, to prevent cardiovascular disease. But consideration of new, "personalised" clinical trial designs and an improved understanding of the biology of precancers, as well as new agents which target their molecular abnormalities, may make the field a more promising investment, says Malini Guha.
Janssen-Cilag's (Johnson & Johnson) injectable drug Xeplion (paliperidone palmitate) has been recommended for European approval by the CHMP for the treatment of schizophrenia.
The CHMP has recommended for European approval Pfizer's Xiapex (collagenase clostridium histolyticum) for the treatment of Dupuytren’s contracture, a potentially debilitating hand condition.