Rituximab (Rituxan®/MabThera®): the first decade (1993–2003)

Abstract

The first antibody approved for the treatment of cancer, rituximab (Rituxan®/MabThera®), underwent clinical development between 1993 and 1996. It fulfilled predictions dating back to the early 1900s regarding the therapeutic effect of antibodies and sparked a renewed interest in this area of research. Rituximab was approved, in the USA in 1997 and in Europe in 1998, for the treatment of patients with non-Hodgkin’s lymphoma. Since then, hundreds of thousands of patients have been treated with rituximab. In 2002, rituximab became the number one anticancer drug worldwide. During its first decade of use (1993–2003), rituximab has had an important impact on treatment strategies for lymphoma and other hematologic malignancies. During the 5 years following approval, its applications expanded beyond non-Hodgkin’s lymphoma to a variety of malignant and non-malignant B-cell disorders. Also, as a result of its early clinical trials, initiatives came about that eventually led to the development of the new international response criteria for non-Hodgkin’s lymphoma. Rituximab has been characterized as the most important therapeutic development of the decade.