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Pilot Study of Rituximab Biosimilar in Newly Diagnosed CLL

By: Sarah Campen, PharmD
Posted: Friday, January 22, 2021

A rituximab biosimilar (Zytux) appears to have similar safety and efficacy outcomes in newly diagnosed patients with chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL) compared with reference rituximab, according to a pilot study published in Hematology Reports. “This study concluded that the early results of use of [biosimilar rituximab] in NHL and CLL were not inferior to reference [rituximab]; in contrast, it was comparable and even better in terms of safety and efficacy,” stated Alaa Fadhil Alwan, MD, of Mustansiriya University, Baghdad, and colleagues.

This study included 20 patients with newly diagnosed CLL (n = 10) and NHL (n = 10), who had a median age of 66. The overall response rate in both groups was 85%; a complete response was achieved in 35% of patients, and a partial response was achieved in the remaining 50%.

Regarding safety, the rituximab biosimilar demonstrated similar adverse reactions compared with previously reported adverse reaction rates with reference rituximab. Grade 1 or 2 infusion reactions were reported in four patients, and no significant difference was observed in the rate of hematologic adverse reactions. “Our recommendation is to conduct a head-to-head, multicenter study with a larger sample size to confirm these results,” the authors concluded.

Disclosure: The study authors reported no conflicts of interest.



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