38. Libtayo

(Sanofi Genzyme/Regeneron)

Active ingredient: cemiplimab-rwlc
Disease: metastatic cutaneous squamous cell carcinoma
Peak sales estimate: $1.4 billion
Approved: Sept. 28
Company: Regeneron and Sanofi

The scoop: Sanofi and Regeneron's new immuno-oncology drug Libtayo is the sixth PD-1 inhibitor to win FDA approval, but it has a niche market to itself. It was approved to treat metastatic cutaneous squamous cell carcinoma (CSCC) in patients who aren’t candidates for curative surgery or radiation. CSCC is the second most common form of skin cancer. Not only is Libtayo the first PD-1/PD-L1 drug to be approved in that indication, it’s the first drug ever approved for the condition. It is expected to have that market to itself for several years, thus the estimated blockbuster sales. Regeneron and Sanofi will, however, seek approval in the very lucrative market for untreated lung cancer and think they might be able to edge out some of the competition for market share. — Eric Palmer

38. Libtayo

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