Roche’s MabThera gets European approval to treat chronic lymphocytic leukaemia
pharmafile | May 31, 2016 | News story | Manufacturing and Production | Roche, chronic lymphocytic leukaemia, drug approval, regulation
Swiss drugmaker Roche (SIX: ROG) on Tuesday said the European Commission (EC) has approved the subcutaneous (SC) formulation of its MabThera (rituximab) to treat chronic lymphocytic leukaemia (CLL).
This is the second European approval for the drug after the approval of MabThera SC as a treatment for common forms of non-Hodgkin lymphoma in March 2014.
Chief Medical Officer 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.”
MabThera is a therapeutic monoclonal antibody that binds to a particular protein on the surface of normal and malignant B-cells. It then recruits the body’s natural defences to attack and kill the marked Bcells.
The European approval was based primarily on data from the Phase Ib study, in which previously untreated CLL patients received either MabThera SC or intravenous MabThera in combination with chemotherapy (fludarabine and cyclophosphamide. The study showed 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, and results were recently published in The Lancet Haematology.
Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in the western world. CLL mainly affects men and the median age at diagnosis is about 70 years. Worldwide, the incidence of all leukaemias is estimated to be over 350,000 and CLL is estimated to affect around one-third of all people newly diagnosed with leukaemia.
Anjali Shukla
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