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   Nimotuzumab (Tai Xin Sheng®) is a humanized IgG1 monoclonal antibody targeting the extracellular domain of EGFR. It has demonstrated blocking ability against the binding of EGF and TGF-alpha to EGFR, and has observed inhibitory activity on tumor cell growth, angiogenesis, and apoptosis. Further, experimental observations demonstrated that in contrast to other approved anti-EGFR antibodies, the intrinsic properties of nimotuzumab require bivalent binding for stable attachment to the cellular surface, leading nimotuzumab have the maximum clinical benefit and absence of severe dermatological toxicity (high uptake in tumors overexpressing the receptor and low uptake in normal tissues). It has been approved for the treatment of advanced head and neck cancer (H&NC), nasopharyngeal cancer (NPC), glioma and esophageal cancer (ESOC) in 30 countries.

   Nimotuzumab (trade name in China Tai Xin Sheng®, Registration ID: 2005S02236) was approved in China in 2008 as a drug in combination with RT for a treatment of NPC and was included within Chinese NCCN guideline as a recommended targeted therapy for this indication in 2009.

   Post marketing experience in NPC reinforces the safety within Chinese population. More than 30,000 patients received this therapy with an excellent safety profile in China and throughout the world. Five phase III clinical trials are ongoing in different tumors from epithelial origin with different schedules of treatment, with the approval of the China Food and Drug Administration (CFDA). For this reason, physicians have used nimotuzumab as an “off-label product” in other cancers of epithelial origin.

   After seven years of the first approval in China, the information of several advanced cancer patients who received nimotuzumab in combination with CT in off-label approach has been collected. This retrospective analysis summarizes the safety profile, efficacy and possible predictive factors of this anti-EGFR therapy in Chinese patients with advanced cancers.

  • Product name: Nimotuzumab

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