In the 1970s, scientists found out that monoclonal antibodies can specifically target tumor cells, which triggered significant changes in cancer treatment since then. BPL has focused on the clinical application of monoclonal antibodies to treat patients with cancer since 1999, and developed China’s first humanized monoclonal antibody Nimotuzumab (Tai Xin Sheng), which was approved to treat patients with nasopharyngeal cancer in China and put into market in 2008. Nimotuzumab targets epidermal growth factor receptor (EGFR), and is believed to be candidate for the treatment of multiple solid tumors, concerning EGFR participates in the occurrence and development of various malignant tumors by leading to cell proliferation and apoptosis. 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.