Swiss pharmaceutical company Roche has received approval from the European Commission (EC) for the subcutaneous (SC) formulation of MabThera (rituximab), to treat people affected with previously untreated and relapsed or refractory chronic lymphocytic leukaemia (CLL).
MabThera is a therapeutic monoclonal antibody that binds to a particular protein called the CD20 antigen, on the surface of normal, as well as malignant B-cells.
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The formulation then allows the body’s natural defences to fight against and kill the marked B-cells.
The SC formulation of MabThera helps save time and also reduces the treatment burden, compared to the intravenous form of administering the medicine.
The current EC approval is the second European approval for MabThera SC after the formulation was approved in March 2014 to treat common forms of non-Hodgkin lymphoma.
The dose that has been approved for CLL is 1,600mg.
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By GlobalDataRoche Global product development chief medical officer and head Dr Sandra Horning said: "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.
"Today’s approval in CLL means the benefit of MabThera SC can be offered to even more patients."
The EC approval was based mainly on data from the Phase Ib SAWYER study, which revealed that treatment with MabThera SC resulted in comparable levels of the medicine in the blood along with necessary efficacy and safety, when compared to intravenous MabThera.
Image: Micrograph of a lymph node affected by B-cell CLL. Photo: courtesy of Nephron.
