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Rituximab Approved in Europe for Patients With Previously-Treated CLL
NEW YORK -- September 3, 2009 -- The European Commission has approved rituximab (MabThera) for use in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL).
The approval is based on results from the randomised Rituximab in the Study of Relapsed Chronic Lymphocytic Leukaemia (REACH) trial.
"This approval will make [rituximab] plus chemotherapy the gold-standard therapy for people living with relapsed or refractory CLL", said lead investigator Tadeusz Robak, MD, Medical University of Lodz, Lodz, Poland.
"Although all patients with CLL will unfortunately eventually relapse, treatment with [rituximab] significantly prolongs remission. This will help ease the burden of the cancer and enable patients to enjoy the relative freedom that comes with this relief from symptoms."
The results of REACH showed that patients with relapsed or refractory CLL who were treated with rituximab in combination with chemotherapy lived an average 10 months longer without their disease progressing, compared with those receiving chemotherapy alone (30.6 months vs 20.6 months).
SOURCE: Roche
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