FDA OKs First Treatment for Advanced Cutaneous Squamous Cell Carcinoma


Cemiplimab-rwlc (Libtayo) is the first and only treatment specifically approved and available for advanced cutaneous squamous cell carcinoma in the United States.

Officials with the FDA have approved cemiplimab-rwlc (Libtayo) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or radiation, Sanofi announced in a press release.

According to the release, CSCC is the second most common form of skin cancer and causes an estimated 7000 deaths each year in the United States. Cemiplimab-rwlc, a fully-human monoclonal antibody targeting the immune checkpoint receptor programmed cell death protein-1 (PD-1), is the first and only treatment specifically approved and available for this indication in the United States.

“Today’s FDA decision is great news for patients with advanced CSCC who previously had no approved treatment options. This is especially true because these patients are no longer candidates for curative surgery or radiation,” lead investigator Michael R. Migden, MD, professor in the departments of dermatology and head and neck surgery at The University of Texas MD Anderson Cancer Center, said in a statement. “Libtayo is an important new immunotherapy option for US physicians to help address a significant unmet need in this patient group.”

The drug was evaluated by the FDA under Priority Review and was approved based on a combined analysis of data from the phase 2 EMPOWER-CSCC-1 clinical trial and a phase 1 clinical trial. Combined results from both trial represent the largest prospective data set in advanced CSCC. The studies included 75 patients with metastatic CSCC, 33 patients with locally advanced CSCC, and 108 patients with combined CSCC.

According to the studies, the treatment demonstrated a 47% objective response rate (ORR) in metastatic CSCC, 49% ORR in locally advanced CSCC, and 47% ORR in CSCC. Additionally, 60% of patients with metastatic CSCC, 63% of patients with locally advanced CSCC, and 61% of patients with combined CSCC had a duration of response of ≥ 6 months.

The most commonly reported adverse reactions were fatigue (29%), rash (25%), and diarrhea (22%). Serious adverse reactions (SAEs) occurred in 28% of patients and SAEs that occurred in at least 2% of patients were cellulitis, sepsis, pneumonia, pneumonitis, and urinary tract infection.

In addition to advanced CSCC, cemiplimab-rwlc is being evaluated for non-small cell lung cancer, basal cell carcinoma, and cervical cancer, along with trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin lymphoma, and non-Hodgkin lymphoma.

According to Sanofi, the recommended dosage of cemiplimab-rwlc is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks, until disease progression or unacceptable toxicity. Cemiplimab-rwlc is available as a single-dose 350-mg vial.

Cemiplimab-rwlc is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.


FDA approves Libtayo (cemiplimab-rwlc) as first and only treatment for advanced cutaneous squamous cell carcinoma [news release]. Sanofi’s website. http://www.news.sanofi.us/2018-09-28-FDA-approves-Libtayo-R-cemiplimab-rwlc-as-first-and-only-treatment-for-advanced-cutaneous-squamous-cell-carcinoma. Accessed September 28, 2018.

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