Libtayo® (Cemiplimab-rwlc) – 2018 FDA Approval

FDA Approval: 9/28/2018

Cutaneous squamous cell carcinoma (CSCC) is the second most deadly skin cancer following melanoma. CSCC leads to about 3,900 to 8,800 deaths per year in the United States. Prior to Cemiplimab approval, there were no FDA-approved treatments for advanced CSCC which is metastatic or where surgery is not an option. The rarity of this disease has made available data regarding treatment options limited, highlighting the need for further study and development of investigational targeted immunotherapy agents for the treatment of advanced CSCC.

Cemiplimab is a fully human monoclonal antibody directed against programmed cell death protein 1 (PD-1). Although there are five marketed PD-1/PD-L1 inhibitors already approved for a variety of indications, cemiplimab is the first to seek approval for CSCC. With a target PDUFA action date set for October 28, 2018, Cemiplimab was on target to be the first FDA-approved treatment for patients with metastatic or locally advanced CSCC who are not candidates for surgery.


For our complete review of
Cemiplimab-rwlc (Libtayo ®):

Executive Summary of Evaluation:


Cemiplimab (Regeneron Pharmaceuticals Inc. / Sanofi-Aventis)







  Breakthrough Therapy Designation


  Priority Review Designation


  FDA Approval


  Patent Expiration


Indications Squamous Cell Carcinoma

Approved (BLA)

Efficacy Squamous Cell Carcinoma

Efficacy reported in Phase II Trial



Clinical Trial data obtained at Accessed: August 23, 2018.

GlobalData Healthcare. “Sanofi and Regeneron’s Cemiplimab Will Be Sixth Marketed PD-1/PD-L1 Inhibitor.” Pharmaceutical Technology, 23 July 2018,

Karia PS, Han J, Schmults CD. Cutaneous squamous cell carcinoma: estimated incidence of disease, nodal metastasis, and deaths from disease in the United States, 2012. J Am Acad Dermatol. 2013 Jun;68(6):957-66.

Migden MR, Rischin D, Schmults CD, Guminski A, Hauschild A, et al. PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2018 Jul 26;379(4):341-351.

“New England Journal of Medicine Publishes Pivotal Cemiplimab Trials Showing Positive Results in Advanced Cutaneous Squamous Cell Carcinoma.” Regeneron Pharmaceuticals, Inc., 4 June 2018,

Pharma Intelligence Center Accessed: August 23, 2018.

“Squamous Cell Carcinoma (SCC).” The Skin Cancer Foundation,

U.S. Food & Drug Administration Drugs@FDA: FDA Approved Drug Products Product Labeling  Accessed: October 15, 2018

U.S. Food & Drug Administration News & Events FDA News Release “FDA approves first treatment for advanced form of the second most common skin cancer”  Accessed: October 15, 2018

Work Group; Invited Reviewers, Kim JYS, Kozlow JH, Mittal B, Moyer J, Olenecki T, Rodgers P. Guidelines of care for the management of cutaneous squamous cell carcinoma. J Am Acad Dermatol. 2018 Mar;78(3):560-578.


Additional 2018 Pipeline Reviews are available in our pipeline library.

Please see the September 2018 FDA Actions Newsletter for additional information on recent FDA approvals


Coauthored by: Kristen Ciampi, PharmD

Kristen recently graduated with a PharmD degree from the University of Rhode Island in May of 2018, and is a Pharmacy Analytics Intern at RJ Health Systems.