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DewDiligence

01/22/21 1:55 PM

#236821 RE: DewDiligence #235185

BMY/EXEL—FDA approves Opdivo/Cabometyx in 1L-RCC:

https://finance.yahoo.com/news/u-food-drug-administration-approves-181800206.html

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.