Randomized, double-blind, pharmacokinetic equivalence trial comparing DRL-rituximab with MabThera in patients with diffuse large B-cell lymphoma
Journal of Global Oncology Dec 13, 2019
Viswabandya A, Shah S, Mukhopadhyay A, et al. - Researchers examined patients having untreated diffuse large B-cell lymphoma (DLBCL) who were eligible to take cyclophosphamide, doxorubicin, vincristine, and prednisone therapy, to compare the pharmacokinetics (PKs) of DRL-rituximab (DRL_RI; potential biosimilar) and innovator rituximab MabThera (Roche, Grenzach-Wyhlen, Germany; reference medicinal product [RMP]) in these patients. They also compared effectiveness, pharmacodynamics (PDs), safety, and immunogenicity in this double-blind, parallel-group study. Random allocation of 151 patients was done (DRL_RI, n = 76; RMP, n = 75). Findings revealed equivalent PKs and comparable effectiveness, PDs, safety, and immunogenicity of DRL_RI and RMP.
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