Nivolumab, the first PD-1 inhibitor, was approved in Japan for treating unresectable melanoma. It has been developed in Japan by Ono Pharmaceutical, which also has rights in Korea and Taiwan.
The first immunotherapy product to act on the programmed death (PD) pathway has just been granted its first approval in the world.
Nivolumab has been approved for use in melanoma in Japan as Opdivo (Ono Pharmaceutical). Ono also has rights to the drug in Korea and Taiwan. The drug is licensed elsewhere to Bristol-Myers Squibb.
This is one of the most highly anticipated drug approvals in oncology — the product has shown unprecedented responses in melanoma, as well as several other tumor types, and the data on this drug have dominated the news coming out of oncology meetings for the last 2 years. It has led to a huge interest in immunotherapy, and manipulation of the PD pathway in particular, and many pharmaceutical companies are investing in this research area, considered to be one of the most promising in the whole cancer field.
The Japanese approval for nivolumab is for use in unresectable melanoma.