BASEL, SWITZERLAND — March 25, 2002 — Revolutionary anti-cancer drug MabThera® (rituximab), combined with standard chemotherapy, was today given approval in Europe for use in fighting an increasingly common form of blood cancer called aggressive non-Hodgkin's lymphoma (NHL).
For thousands of patients across Europe, this decision by the European Medicines Evaluation Agency (EMEA) will mean availability of a drug combination that can increase the chance of cure and prolong survival in this rapidly fatal form of cancer.
The EMEA's decision was based on results looking at MabThera plus standard chemotherapy (CHOP) versus CHOP alone in the pivotal GELA (Groupe d'Etude des Lymphomes de l'Adulte) study. CHOP chemotherapy uses the drugs cyclophosphamide, doxorubicin, vincristine, and prednisolone. The interim analysis looked at 328 out of the enrolled 399 previously untreated elderly patients (60 years or older) with aggressive NHL. Patients were randomised to receive standard CHOP chemotherapy alone (every three weeks for eight cycles) or MabThera (375 mg/m²) plus CHOP. MabThera was administered at the same time as CHOP for eight cycles.