The European Commission has approved a subcutaneous formulation of Roche's MabThera for chronic lymphocytic leukaemia, saving time and easing the treatment burden compared with drug's intravenous form, says the drugmaker.
The decision allows use of subcutaneous MabThera (rituximab) to treat people with previously untreated and relapsed/refractory forms of the blood cancer, and follows its clearance for patients with non-Hodgkin lymphoma in March 2014.
"MabThera SC provides patients with significantly faster treatment administration and the opportunity to enjoy more time outside the clinical setting compared to intravenous delivery of the medicine," commented Sandra Horning, chief medical officer and head of Global Product Development at Roche.
Approval was based primarily on data from the phase Ib SAWYER study, in which previously untreated CLL patients received either MabThera SC or intravenous MabThera in combination with chemotherapy (fludarabine and cyclophosphamide), a current standard of care.
SAWYER showed that treatment with MabThera SC resulted in comparable levels of the medicine in the blood (serum concentrations), as well as efficacy and safety, to intravenous MabThera, Roche noted.