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Accessed October 8, 2025. The estimated 24-month DFS was approximately 87.1% (95% CI, 80.3–91.6) with cemiplimab and 64.1% (95% CI, 55.9–71.1) with placebo. ClinicalTrials.gov identifier: NCT03969004. The estimated 24-month disease-free survival was 87.1% (95% CI, 80.3 to 91.6) with cemiplimab and 64.1% (95% CI, 55.9 to 71.1) with placebo. Additionally, the agent has been approved by regulatory authorities for use in certain adult patients with advanced basal cell carcinoma, CSCC that is advanced or at high risk of recurrence, advanced non–small cell lung cancer, and advanced cervical cancer.1,2

“CSCC is one of the most common skin cancers in the world, with an estimated 1.8 million cases diagnosed each year in the US alone.

Discontinuation because of these AEs occurred in 9.8% and 1.5% of patients, respectively.4

“Many patients who undergo surgical resection of their CSCC are later found, on full pathological evaluation, to be at high risk of recurrence. Updated September 19, 2025. Accessed October 8, 2025. 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,” Vishal A.

Patel, M.D., associate professor of dermatology and hematology/oncology at George Washington University, and director of the GW Cancer Center’s Cutaneous Oncology Program, 

for dystrophic epidermolysis bullosa patients at birth

In September 2025, the FDA expanded the label for (beremagene geperpavec) to include dystrophic epidermolysis bullosa patients from birth.

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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.

You will receive an email when new content is published. Results were published in The New England Journal of Medicine.3,4

The median follow-up was approximately 24 months. doi:10.1056/NEJMoa2502449

FDA Approves Cemiplimab as Adjuvant Immunotherapy for High-Risk CSCC

Last week, Regeneron announced the U.S.

Food and Drug Administration (FDA) approval of cemiplimab-rwlc (Libtayo) as an adjuvant treatment for adult patients with cutaneous squamous cell carcinoma (CSCC), particularly in those with a high risk of recurrence after surgery and radiation.1 The PD-1 inhibitor was evaluated under priority review.

"The FDA approval of Libtayo as the first and only immunotherapy for adjuvant treatment of CSCC with a high risk of recurrence after surgery and radiation is a pivotal moment for patients battling this disease,” Israel Lowy, MD, PhD, Clinical Development Unit Head of Oncology at Regeneron, told Dermatology Times.

US Food & Drug Administration. "This amazing foam vehicle not only delivers the highly potent PDE4 inhibitor roflumilast to the sites where patients need it most, but it does so in an elegant fashion. In this vulnerable patient population, an additional regulatory application is under review in the European Union, with a decision expected in early 2026.

"Patients whose CSCC is at a high risk of recurrence following surgery and radiation often have the poorest outcomes.

“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. The drug was originally approved in 2023.

Dystrophic epidermolysis bullosa is a rare subtype of epidermolysis bullosa characterized by extreme skin fragility affecting the deeper dermal layer beneath the epidermis.

Dupixent for bullous pemphigoid, chronic spontaneous urticaria

https://www.managedhealthcareexecutive.com/view/regeneron-s-libtayo-fda-approved-as-first-immunotherapy-to-reduce-recurrence-risk-in-high-risk-skin-cancer-patients

In June 2025, the FDA approved Dupixent as a treatment for adult patients with bullous pemphigoid (BP), a rare inflammatory skin disease.

3. Regeneron.