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Patients were required to complete adjuvant radiation therapy within 2 to 10 weeks of randomization.

Results showed median DFS of 49.4 months with placebo, but was not yet reached with cemiplimab-rwlc (HR = 0.32; 95% CI, 0.2-0.51).

The FDA-recommended dose for cemiplimab-rwlc is 350 mg IV every 3 weeks for 12 weeks, followed by 700 mg every 6 weeks, or 350 mg every 3 weeks until disease recurrence, unacceptable toxicity or up to 48 weeks.

FDA Approves Cemiplimab as Adjuvant Treatment for Cutaneous Squamous Cell Carcinoma

The FDA approved cemiplimab-rwlc (Libtayo; Regeneron Pharmaceuticals) for the adjuvant treatment of adults with cutaneous squamous cell carcinoma (CSCC) who are at a high risk of recurrence following surgery and radiation.

Rischin D, Porceddu S, Day F, et al. Earlier in April, the FDA approved the resubmitted application of Dupixent (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU).

Dupixent, a mainstay of treatment of inflammatory skin conditions, inhibits the signaling of interleukin-4 and interleukin-12, key drivers of the type 2 inflammation that underlies many chronic allergic and inflammatory conditions.

as a treatment for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease.

Bullous pemphigoid is an autoimmune skin disorder that mainly affects older adults.

At Regeneron, we remain steadfast in our commitment to advancing research and creating new innovative possibilities for patients.”

Supporting Phase 3 Research

The approval is supported by data from the phase 3 C-POST trial, which was published in the New England Journal of Medicine and presented at the American Society of Clinical Oncology Annual Meeting earlier this year.² In the global, randomized, double-blind, placebo-controlled study, 415 patients were assigned in a 1:1 ratio to receive adjuvant cemiplimab (350 mg) or placebo, administered intravenously every 3 weeks for 12 weeks, followed by a dose increase to 700 mg administered every 6 weeks.

Compared to placebo, cemiplimab significantly reduced the risk of disease recurrence or death by 68% (HR: 0.32; 95% CI: 0.20-0.51; p < 0.0001).

But more than 300,000 people in the United States have chronic spontaneous urticaria that is inadequately controlled by antihistamines.

FDA approves cemiplimab as adjuvant treatment for cutaneous squamous cell carcinoma

October 09, 2025

1 min read

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“This approval not only reaffirms Libtayo’s position as a versatile PD-1 inhibitor with 5 approved indications in the US but offers a truly practice-changing advancement.

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2. October 8, 2025.

Although PDE4 inhibition is not new — it is the mechanism of action of treatments such as Eucrisa (crisaborole) and Otezla — Zoryve — is a more potent PDE4 inhibitor. The findings indicated that cemiplimab was superior to placebo regarding DFS (24 vs 65 events; HR for disease recurrence or death, 0.32 [95% CI, 0.20–0.51]; P < .001).

In a clinical trial, cemiplimab demonstrated superiority to placebo when treating patients with CSCC.¹
Cemiplimab is a fully human monoclonal antibody that targets the immune checkpoint receptor PD-1 on T cells. In 2022, the FDA it as a treatment for nonsegmental vitiligo.
https://www.dermatologytimes.com/view/fda-approval-brings-new-non-steroidal-option-for-pediatric-ad
Libtayo for adjuvant squamous cell carcinoma therapy
In October 2025, the FDA approved Libtayo (cemiplimab) as a treatment for cutaneous squamous cell carcinoma that has a high risk of recurring after it has been treated with surgery and radiation.
As a PD-1 inhibitor, Libtayo targets receptors on T cells and, in doing so, unleashes the T cells so they recognize and attack cancer cells.
“A rapid, steroid-sparing option that meaningfully reduces itch within days helps us control flares without escalating to systemic therapy and can help minimize the use of topical steroids.”
The approval was based on the phase 3 TRuE-AD3 study, which enrolled 330 children ages 2 to 11 years with mild to moderate atopic dermatitis. Accessed October 13, 2025.

News release. Until now, we lacked options to help prevent a devastating recurrence and immunotherapy was only available for patients with advanced CSCC who were no longer candidates for curative surgery or curative radiation,” said Vishal A. Patel, MD, associate professor of dermatology at the George Washington University School of Medicine & Health Sciences.

“Now with 5 FDA-approved indications, Libtayo is firmly established as a strong and versatile PD-1 inhibitor option for patients with a variety of cancers.”¹
Next Steps and Final Thoughts
Cemiplimab is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells.

2025;393(8):774-785. Adjuvant Cemiplimab or Placebo in High-Risk Cutaneous Squamous-Cell Carcinoma. The original approval was as a treatment for metastatic cutaneous squamous cell carcinoma or locally advanced in individuals who weren’t candidates for curative surgery or curative radiation.
“Patients whose CSCC [cutaneous squamous cell carcinoma] is at a high risk of recurrence following surgery and radiation often have the poorest outcomes.

Adjuvant Cemiplimab or Placebo in High-Risk Cutaneous Squamous-Cell Carcinoma. It is designed to deliver two copies of the COL7A1 gene when applied directly to dystrophic epidermolysis bullosa wounds. Please try again later.