Celltrion announced today that the results of post-marketing clinical trials of the blood cancer treatment Truxima (development name: CT-P10, component name: Rituximab) have been published in a prominent international journal.
The journal "Expert Opinion on Biological Therapy," in which the results were published, mainly deals with the field of biological treatment and is evaluated as a trusted Science Citation Index (SCI) journal in the industry.
The results of the study are an analysis of data collected from 27 centers in Korea for about four years from November 2016 to November 2020.
Post-marketing Surveillance (MS) confirmed the safety and efficacy of Truxima after administration to 677 patients throughout the nation's licensed indications, including non-Hodgkin lymphoma (NHL), rheumatoid arthritis (RA), chronic lymphocytic leukemia (CLL), Wegener's Granulomatosis (WG), and Microscopic polyangitis (MPA).
According to these results, Truxima showed a similar level of safety to the original drug and Truxima approved clinical results.
In addition, positive results have been derived, with high response rates across patients across domestic licensed indications as well as non-Hodgkin lymphoma (NHL) and rheumatoid arthritis (RA) indications that have already secured meaningful data through previous clinical trials.
Celltrion believes that the safety and effectiveness of Truxima will be confirmed at the actual medical site and the research results will be published in a reliable journal, which will have a positive impact on the expansion of Truxima prescriptions in the future.
Truxima obtained a South Korean sales license from the Ministry of Food and Drug Safety in 2016, received a sales license from the European Medicines Agency (EMA) in 2017, and the U.S. Food and Drug Administration (FDA) in 2018 and is being supplied to major global markets.
Truxima achieved 23.6% of the European market as of the second quarter of last year and 27.6% of the U.S. market as of the third quarter of last year.
An official from Celltrion said, "We hope that the results of this study will be published in international journals and serve as a significant basis for expanding the prescription of Truxima in the future medic
