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“As the first and only immunotherapy approved in the adjuvant setting, Libtayo represents a practice-changing opportunity for this patient population, backed by compelling data showcasing its ability to significantly improve disease-free survival.”

The FDA based the approval on data from the randomized, placebo-controlled C-POST trial, which included 415 patients with cutaneous cell squamous carcinoma at high risk for recurrence after surgery and radiation.

Patients randomly assigned to the investigational regimen received 350 mg IV cemiplimab-rwlc every 3 weeks for four cycles followed by 700 mg IV cemiplimab-rwlc every 6 weeks for 36 weeks.

Additionally, cemiplimab was observed to lead to lower risks of locoregional recurrence (9 vs 40 events; HR, 0.20 [95% CI, 0.09–0.40]) and distant recurrence (10 vs 26 events; HR, 0.35 [95% CI, 0.17–0.72]).⁴

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

The symptoms include severe itching, blisters, lesions and skin breakdown. 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.

US Food & Drug Administration. It is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control symptoms of urticaria.

While it can often be treated successfully with surgery and radiation, many patients face serious risk of advanced disease recurrences,” Samantha R. Guild, president of AIM at the Skin Cancer Foundation, said in a news release from Regeneron.²

What Do the Data Show?

The approval of cemiplimab is supported by pivotal data from the randomized, placebo-controlled, double-blind phase 3 clinical trial, C-POST (NCT03969004), which assessed adjuvant cemiplimab compared with placebo following surgery and radiation therapy in 415 patients with high-risk CSCC.

News release. N Engl J Med. The drug is currently being investigated for use as a monotherapy as well as in combination with other approaches for other solid tumors and blood cancers. 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.

2. As the first and only immunotherapy approved in the adjuvant setting, Libtayo represents a practice-changing opportunity for this patient population, backed by compelling data showcasing its ability to significantly improve disease-free survival.”¹

References

1.

4. The changes to the label also changed the wound dressing requirements to make at-home use of Vyjuvek feasible.

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Krishnan, chairman and CEO of Krystal Biotech, the drug’s maker, said in a news release that by “providing patients and their caregivers the ability to apply Vyjuvek themselves, we have made it easier for patients to integrate Vyjuvek into their daily routines and lifestyle.”

Vyjuvek is a herpes-simplex virus type 1 vector-based gene therapy indicated for the treatment of dystrophic epidermolysis bullosa with mutations in the (COL7A1) gene.

The primary end point was disease-free survival (DFS), and secondary end points included overall survival (OS), freedom from distant recurrence, and frequency and incidence of adverse events (AEs), among others.

"It is spectacular that roflumilast 0.3% foam is now approved for scalp and body psoriasis in adolescents and adults," said Dermatology Times Editor in Chief Christopher Bunick, M.D., Ph.D., in an interview.

The label expansion made Opzelura the first topical Janus kinase (JAK) inhibitor approved for the pediatric population in the U.S. .

“This gives us another tool in a much-needed area,” Peter Lio, MD, a clinical assistant professor of dermatology and pediatrics at Northwestern University Feinberg School of Medicine and founding director of the Chicago Integrative Eczema Center, told Dermatology Times.

Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma. Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First and Only Immunotherapy for Adjuvant Treatment of Cutaneous Squamous Cell Carcinoma (CSCC) with a High Risk of Recurrence After Surgery and Radiation.

3. As the first and only immunotherapy approved in the adjuvant setting, [cemiplimab] represents a practice-changing opportunity for this patient population, backed by compelling data showcasing its ability to significantly improve disease-free survival,” Patel said in the news release.²

REFERENCES

1.

A study published in the Journal of the American Academy of Dermatology estimated the prevalence in the U.S. to be 12 per 100,000 adults, which increases to nearly 38 per 100,000 among those aged 60 and older.

Chronic spontaneous urticaria is a chronic inflammatory skin disease driven in part by type 2 inflammation.

Updated September 19, 2025. Published October 8, 2025. October 8, 2025.