FDA Approves Libtayo for Cutaneous Squamous Cell Carcinoma Treatment

The Food and Drug Administration (FDA) has approved Libtayo (cemiplimab-rwlc) for the adjuvant, or postsurgical, treatment of adults with cutaneous squamous cell carcinoma (CSCC) at high risk of recurrence after surgery and radiation, the agency has announced.

Effectiveness of the drug was determined in the C-POST randomized, double-blind, multicenter, placebo-controlled trial of 415 patients with CSCC who were at a high risk of recurrence following surgery and radiation.

In the trial, patients were required to complete postsurgical radiation therapy within two to 10 weeks of randomization, and the study excluded patients with autoimmune disease who required systemic immunosuppressant agents within five years, a history of solid organ transplant, prior allogenic or autologous stem cell transplantation, uncontrolled HIV, hepatitis B or C infection or an ECOG performance status of 2 or higher. Patients in the trial were evenly randomized to receive Libtayo or placebo.

Median disease-free survival, or the time from randomization until the first documented disease recurrence or death due to any cause, was not reached in the Libtayo arm and 49.4 months in the placebo arm.

The prescribing information of Libtayo, according to the news release, includes warnings and precautions for immune-mediated side effects, infusion-related reactions, complications of allogenic hematopoietic stem cell transplantation and embryo-fetal toxicity.

The agency further stated that the recommended dosage of Libtayo is 350 milligrams (mg) administered intravenously, or into the vein, every three weeks for 12 weeks, followed by 700 mg every six weeks or 350 mg three weeks until disease recurrence, unacceptable toxicity or for up to 48 weeks.

More on Libtayo and the C-POST Study

“When we looked at the C-POST study, we actually discovered that those patients who, for example, got anti-PD-1 therapy — in the case of the C-POST study, it was Libtayo — and they also compared it to an arm of patients who got placebo, they actually found statistical significance in terms of disease recurrence,” Dr. Vincent Ma, a faculty member in the Division of Hematology, Medical Oncology and Palliative Care at the University of Wisconsin, said in an interview with CURE earlier this year.

“Overall, I think the conclusion from the study is that because we saw a disease-free survival benefit from patients who received adjuvant Libtayo for one year in the C-POST study, it is likely to eventually become standard of care in the future for patients who have high-risk squamous cell carcinoma of the skin following surgery and radiation,” he noted.

Libtayo, as explained by the National Cancer Institute on its website, is a drug that binds to the protein PD-1 to help immune cells kill cancer cells better. It is used to treat certain types of basal cell carcinoma and cutaneous squamous cell carcinoma, which are types of skin cancer, that are locally advanced or have spread to other parts of the body. It is also used alone or in combination with other drugs in order to treat some adults with non-small cell lung cancer, and is being studied in the treatment of other types of cancer. Libtayo, the National Cancer Institute explained, may block PD-1 and help the patient’s immune system kill cancer cells, and it is a type of monoclonal antibody and a type of immune checkpoint inhibitor.

References

1. “FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma,” FDA; https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma?utm_medium=email&utm_source=govdelivery
2. “Key Skin Cancer Treatment Updates From 2025 and What is Still to Come,” CURE; https://www.curetoday.com/view/key-skin-cancer-treatment-updates-from-2025-and-what-is-still-to-come
3. “Libtayo,” National Cancer Institute; https://www.cancer.gov/publications/dictionaries/cancer-terms/def/libtayo

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