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.