Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Roche has submitted a marketing authorization application to the European Medicines Agency for the use of its biotechnology drug MabThera as the first-line treatment of chronic lymphocytic leukaemia, the most common form of adult leukaemia.
Subscribe to our email newsletter
The filing is based on data from the pivotal Phase III chronic lymphocytic leukaemia (CLL) 8 study, initiated by the German CLL Study Group, which showed at interim analysis that treatment with MabThera in combination with the current standard chemotherapy achieved a significantly better outcome, compared to patients treated with chemotherapy alone.
The study was designed to show an increase in progression free survival when the MabThera-based combination was used. Full results of the CLL8 study are expected to be be submitted in December 2008.