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Libtayo Approval History

FDA Approved: Yes (First approved September 28, 2018)
Brand name: Libtayo
Generic name: cemiplimab-rwlc
Dosage form: Injection
Company: Sanofi
Treatment for: Squamous Cell Carcinoma

Libtayo (cemiplimab-rwlc) is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC).

Development History and FDA Approval Process for Libtayo

DateArticle
Sep 28, 2018Approval FDA Approves Libtayo (cemiplimab-rwlc) for Advanced Cutaneous Squamous Cell Carcinoma
Jun  4, 2018New England Journal of Medicine Publishes Pivotal Cemiplimab Trials Showing Positive Results in Advanced Cutaneous Squamous Cell Carcinoma
Apr 30, 2018FDA to Conduct Priority Review of Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
Dec 13, 2017Sanofi and Regeneron Announce Positive Topline Pivotal Results for PD-1 Antibody Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma
Sep  8, 2017Sanofi and Regeneron Announce That Cemiplimab (REGN2810) has Received FDA Breakthrough Therapy Designation for Advanced Cutaneous Squamous Cell Carcinoma

Further information

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