Takeda Pharmaceutical Company Limited and Takeda Bio Development Center Limited (Takeda Bio) announced that they submitted a New Drug Application of anti-cancer agent, panitumumab (recombinant) (panitumumab) for the treatment of patients with progressed and/or relapse colorectal cancer to the Ministry of Health Labour and Welfare in Japan.
Panitumumab is a fully-human monoclonal antibody which binds to epidermal growth factor receptor (EGFr), and suppresses tumour growth. It shows a low incidence of allergic reaction upon and also after administration as it is a fully-human monoclonal antibody.
Panitumumab was originally developed by Amgen Inc. and is marketed by Amgen in the US and EU under the brand name of Vectibix, and Takeda Bio has been conducting the development activities in Japan.
"We believe the NDA submission of panitumumab will lead to the enhancement of our oncology franchise, one of our core therapeutic areas," said Masaomi Miyamoto, Ph.D., general manager of Pharmaceutical Development Division of Takeda. "We expect to offer panitumumab as early as possible to the patients with colorectal cancer, which is increasing in number in Japan, and healthcare providers, as a new treatment option different from existing chemotherapies."
"We are very much pleased with this milestone event which is the first NDA submission since the start of our company as Takeda Bio Development Center Limited," said Hiroyasu Nakamura, president of Takeda Bio. "We are committed to realization of the Mission of Takeda group, "striving toward better health for individuals and progress of medicine by developing superior pharmaceutical products", through determined engagement in the clinical development of innovative products, including antibody medicines, in the therapeutic areas such as oncology, licensed from Amgen to Takeda."