Roche Receives Positive Opinion For Use Of MabThera

The EU’s Committee on Human Medicinal Products (CHMP) has issued a positive recommendation for the use of Roche’s MabThera (rituximab) in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL). MabThera is the monoclonal antibody therapy approved for previously untreated CLL in combination with chemotherapy, for patients who have been treated but whose cancer has returned or have not appropriately responded to therapy.

The recommendation is based on the results from REACH, the randomised clinical trial reported in previously treated CLL. The results showed that patients with relapsed or refractory CLL, who received MabThera in combination with chemotherapy, lived an average ten months longer (without their disease progressing), compared to those receiving chemotherapy alone (30.6 months vs 20.6 months).

William Burns, CEO, Roche, said: “MabThera has been shown to give patients significantly more time without their disease worsening compared to those receiving chemotherapy alone. The positive opinion will, therefore, be welcomed by doctors and patients alike as it represents hope for the future management of a disease that remains notoriously difficult to treat.”