Zevalin in aggressive Lymphoma trial

German drugmaker Schering AG and US biotechnology firm Biogen Idec say that they have begun a Phase III trial of the radioimmunotherapy product Zevalin (ibritumomab tiuxetan) in aggressive forms of lymphoma. Schering, which licensed rights to the product outside the USA from Biogen, said that the study would compare the treatment efficacy and safety of Zevalin with observation in patients with diffuse large-B-cell lymphoma, who are in complete remission after first-line therapy with CHOP-rituximab based chemotherapy.

Schering added that it will aim to enroll 400 patients into the program, which will be a radomized, dual-arm, group sequential study, undertaken at 103 sites worldwide for a period of four years. The assessment's primary endpoint will be overall survival, with health-related quality-of-life measures as secondary criteria. The firm added that, both itself and Biogen intend to file for the expanded indication when the trial has been completed.