The approval is based on the CHECKMATE-9ER study (#msg-155130561). The FDA review of the combination regimen was an unusual combination of an NDA (for Cabo, a small molecule) and a BLA (for Opdivo).
Edit: Just saw than vinmantoo posted this news. I'll leave my post up anyhow since it provides some of the background info.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.