Halozyme Therapeutics and Roche announced initiation of their Phase 3 study of subcutaneous MabThera (rituximab) for the treatment of NHL. This study is a two-stage, international, multicenter, randomized, controlled, open-label trial studying the pharmacokinetics, efficacy, and safety of rituximab SC versus rituximab IV in patients with previously untreated follicular NHL. The primary efficacy endpoint of stage I is to estimate the ratio of trough serum concentrations of MabThera after SC administration to that obtained after IV administration (time frame: Day 21). The primary outcome for stage II is to estimate the overall response rate in each treatment arm at the end of induction treatment (time frame: Week 24 [Cycle 8]).
MabThera is an anticancer biologic approved to treat NHL and chronic lymphocytic leukemia (CLL) when administered intravenously.
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