FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Sanofi Snags Canadian Approval for Skin Cancer Drug

April 22, 2019

Health Canada approved Sanofi’s immunotherapy Libtayo (cemiplimab) for cutaneous squamous cell carcinoma (CSCC).

The drug is now cleared for use by patients with CSCC who aren’t candidates for surgery or radiation.

Libtayo is Canada’s first approved biologic treatment for advanced CSCC. The marketing authorization is currently pending until studies confirm its clinical benefit, the agency said.

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