Even before I wrote this little story, as I was getting my last dose of Nivolumab in June of 2013, Love Potion...or Patient...#9!!!!! which includes this history of Opdivo's development ~
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 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 is conducting Phase II studies with ONO4538 in non small cell lung cancer and melanoma and Phase III studies in renal cell carcinoma currently. However, no results of either of those studies can be found. Thus began the exploration of BMS 936558 in the Americas!
~ to as recently as this past November when I put together this post (which covers the results of the CheckMate-238 trial): Review of adjuvant treatment in Stage III melanoma and "death knell" for ipi and interferon in that role!!!! I have NEVER stopped SCREAMING about the obvious need to approve anti-PD-1 for the adjuvant treatment of melanoma in Stage III AND IV patients!!
Thanks to all the ratties and researchers who kept pushing....as of 4 days ago - it's finally done: FDA Approves Adjuvant Nivolumab for Melanoma
The OncLive link above notes: "The FDA has approved nivolumab (Opdivo) as an adjuvant treatment for patients with completely resected melanoma with lymph node involvement or metastatic disease, based on findings from the phase III CheckMate-238 trial."
Here's a synopsis of Opdivo's approvals by the FDA: History of Opdivo from Drugs.com