Ono receives marketing approval for Opdivo in Japan

Japan-based company Ono Pharmaceutical (TYO: 4528) has received approval for the manufacturing and marketing of Opdivo (nivolumab) to treat unresectable melanoma from the domestic regulator, the Ministry of Health Labor and Welfare (MHLW).

In Japan there is an unmet need for effective treatment for patients with surgically unresectable melanoma, who tend to have a particularly poor prognosis, which Ono believes its new product can address. Currently, only dacarbazine monotherapy is available as standard drug therapy for advanced melanoma in Japan.

Opdivo is a human anti-human PD-1 monoclonal antibody, and is the world’s first approved drug that targets PD-1. The receptor PD-1 is expressed on the surface of lymphocytes and forms part of a regulatory pathway that suppresses activated lymphocytes in the body. Evidence suggests cancer cells exploits this pathway to escape from immune responses. Opdivo enhances the ability of the immune system to recognize cancer cells as being foreign and to be eliminated.