Credit goes to Rick who posted this article on MIF: http://www.fiercebiotech.com/story/anti-pd-1-cancer-star-nivolumab-wins-worlds-first-regulatory-approval/2014-07-07
Some folks seem surprised by Japan acquiring the world's first regulatory approval for anti-Pd1....but the history of the drug tells the tale. From a prior blog post.....
"Once upon a time (2005), in a land far, far away...(Japan), ONO Pharmaceutical generated ONO4538, an anti-PD1 monoclonal antibody, in research collaboration with Medarex (who called the product, MDX1106). In 2009, the big, getting ever bigger, (? benevolent) King of the World, Bristol-Myers Squibb (BMS) acquired the rights to develop ONO4538/MDX1106/BMS936558 (now called Nivolumab) in North America. In an additional agreement in 2011, BMS attained the rights to the product in the rest of the world...except Japan, Korea, and Taiwan...where ONO retained exclusive development rights and conducted Phase II studies with ONO4538 in non small cell lung cancer and melanoma and Phase III studies in renal cell carcinoma currently. However, results of those studies are hard to find."
Hopefully FDA approval will not be far behind! Thanks, Rick! Celeste