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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
Published on: May 4, 2017
Rituximab by subcutaneous route
1Institut de Cancérologie de l'Ouest, Saint-Herblain, Bld Jacques Monod 44805 Saint-Herblain Cedex, France.
Rituximab has become a keystone of the treatment of B-cell lymphoproliferation. The standard administration route is intravenous infusion with risks of infusion-related reactions. In order to make administration easier, increase convenience for the patient and improve cost effectiveness, a subcutaneous (sc.) form has recently been developed. Early phase clinical studies in patients with follicular lymphoma have shown that a fixed dose of 1400 mg by sc. route yielded at least non-inferior pharmacokinetics that are at least as good as those of intravenous rituximab, as measured by Ctrough levels. The safety profile was also comparable. Preliminary analyses of clinical efficacy showed at least non-inferior response rates. Although additional information is required, these results suggest that sc. rituximab may become a useful option for treating patients with B-cell non-Hodgkin's lymphoma.
Rituximab has become a keystone of the treatment of B-cell lymphoproliferation. The standard administration route is intravenous infusion with risks of infusion-related reactions. In order to make administration easier, increase convenience for the patient and improve cost effectiveness, a subcutaneous (sc.) form has recently been developed. Early phase clinical studies in patients with follicular lymphoma have shown that a fixed dose of 1400 mg by sc. route yielded at least non-inferior pharmacokinetics that are at least as good as those of intravenous rituximab, as measured by Ctrough levels. The safety profile was also comparable. Preliminary analyses of clinical efficacy showed at least non-inferior response rates. Although additional information is required, these results suggest that sc. rituximab may become a useful option for treating patients with B-cell non-Hodgkin's lymphoma.
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