Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Libtayo for Metastatic cSCC

Sanofi news release; 2018 Sep 28

The US Food and Drug Administration (FDA) has approved Libtayo (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1

(programmed cell death protein-1) and is the first and only treatment specifically

approved and available for advanced cSCC in the US. cSCC is the second most common skin cancer in the US

Libtayo is manufactured by both Regeneron and Sanofi, headquartered in Eastview, NY, and Paris, France, respectively.

Dosage/administration: The recommended dosage of Libtayo is 350 mg as an intravenous infusion over 30 minutes every 3 weeks.

Adverse effects: The most common adverse reactions (incidence ≥20%) were fatigue, rash,

and diarrhea.


FDA approves Libtayo (cemiplimab-rwlc) as first and only treatment for advanced cutaneous squamous cell carcinoma. [news release]. Eastview, NY, and Paris, France: Regeneron Pharmaceuticals, Inc. and Sanofi. September 28, 2018. Accessed October 1, 2018.

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Psoriasis and Cardiometabolic Comorbidity in Women, Acta Derm Venereol; 2019 Mar 1; Blegvad, et al

Must Reads in FDA Actions

FDA Approves Hyrimoz for Plaque Psoriasis, Sandoz news release; 2018 Oct 31

FDA Approves Seysara for Severe Acne Vulgaris, Paratek Pharmaceuticals, Inc. news release; 2018 Oct 2

FDA Approves Nuzyra for Acute Skin Infections, Paratek Pharmaceuticals, Inc. news release; 2018 Oct 2

Psoriasis Treatment Receives Tentative FDA Approval, Bausch Heath news release; 2018 Oct 8

FDA Approves Libtayo for Metastatic cSCC, Sanofi news release; 2018 Sep 28