Bukwang Pharmaceutical Co., Ltd. announced receipt of orphan drug designation for apatinib mesylate as 3rd-line treatment for gastric cancer from the Korean Ministry of Food and Drug Safety (MFDS). Apatinib is a targeted anti-cancer agent currently under clinical development by Bukwang.
According to Bukwang’s representative, there are standardized 1st- and 2nd-line chemotherapies for gastric cancer, which allows appropriate treatment of patients up to the 2nd line. “However, there are no standardized and suitable treatments available for patients who failed or did not respond to the 2nd-line chemotherapy. Therefore, a 3rd-line treatment is necessary to give hopes of longer life expectancy to those patients suffering from gastric cancer,” the representative said.
The orphan drug designation is expected to help speed up the development of apatinib mesylate in Korea, currently conducted by Bukwang.
Apatinib mesylate selectively inhibits VEGFR-2 among the receptors of VEGF (vascular endothelial growth factor) which is secreted by tumor cells to promote angiogenesis, or formation of new blood vessels. In this way, apatinib mesylate effectively curbs growth and metastasis of tumor cells while at the same time minimizing undesirable side effects. Results from the phase 1 part of the multinational phase 1/2a clinical trial conducted simultaneously in Korea and the US were presented at ASCO last year. In China, apatinib mesylate was launched as 3rd-line treatment for gastric cancer following approval in October 2014, contributing to appropriate treatment of gastric cancer patients in that market.