May News You Can Use Editorial

 Skin Cancer Awareness Month: Updates in Non-Melanoma Skin Cancer

By: Lauryn R. Reid, MD

Non-melanoma skin cancer is the most common type of malignancy worldwide.1 Exciting recent advancements in the field of non-melanoma skin cancer range from new prevention recommendations to treatment modalities. Let’s get into the details.

Prevention

Primary prevention of skin cancer is the ultimate goal for patients and dermatologists alike. In November 2025, congress passed the Safe Sunscreen Standards Act. This act permits the Food and Drug Administration to accelerate the approval process for active ingredients in sunscreen. The FDA last approved new ingredients in sunscreen over 26 years ago,2 placing the United States behind other countries who have continuously modernized UV filters. Recently the FDA proposed bemotrizinol for usage in sunscreen in concentrations up to 6%. Bemotrizinol has properties capable of higher UVA and UVB absorption than traditional active ingredients with an excellent safety profile. If the proposition goes as planned, the synthetic ingredient should be approved by the end of year.2

In 2015, a rule was proposed to the FDA to ban children below the age of 18 from using tanning beds. In March 2026, the FDA withdrew this proposed rule.3 Will minors be influenced by external factors such as peers and social media to partake in usage of tanning beds without fully understanding the consequences? The long-term implications of this provision remain unclear.

Non-Invasive Therapy

While some patients are poor surgical candidates, others simply defer surgery for non-melanoma skin cancers. An approach for this subset of patients is “watchful waiting” (WW). Recent studies have provided increasing evidence for WW as a viable treatment modality. In April 2025, a cohort study reported less than 2% of non-melanoma malignancies recurred with WW after the initial biopsy site healed.5 Independent patient factors and shared decision-making should be utilized to determine when clinical monitoring may be optimal.  

The photosensitizer Ameluz, aminolevulinic acid HCL 10% topical gel, became FDA approved for field therapy for actinic keratosis in 2016. Recent evidence indicates Ameluz in combination with RhodoLED red light lamps can be used to treat superficial basal cell carcinomas. A multicenter cohort study indicated an 83.4% clinical clearance rate of superficial BCCs with Ameluz versus placebo, with favorable cosmesis.6 Ameluz is currently under FDA review and has a target date of late September 2026 for this indication, offering an alternative therapy for patients who struggle to comply with topicals chemotherapeutics or are poor surgical candidates.

The role of immunotherapy in cutaneous malignancy continues to expand. A phase I pilot study found intralesional cemiplimab dosed at 5 mg every six weeks was both efficacious and tolerable for early-stage cutaneous SCC.7 The phase III clinical trials are pending. 

Medicus Pharma has clinical trials underway for evidence to support the usage of doxorubicin microneedle array (D-MNA) in the treatment of nodular basal cell carcinoma. The phase II clinical trials determined individuals treated with 200 μg of D-MNA achieved 73% clinical clearance and 40% histological clearance at day 57.8 More data is anticipated in early to mid 2026. 

Adjuvant Therapy

In October 2025, cemiplimab (Libtayo) became the first FDA approved adjuvant immunotherapy for SCC at high risk for recurrence after surgery and radiation. Adjuvant cemiplimab reduced the risk of disease recurrence or death by 68% compared to placebo, with an excellent safety profile. Additional studies are needed to determine overall survival. Rare side effects reported in the study include injection-site reactions, pruritus, and cutaneous eruptions.9

The association between Merkel cell carcinoma and polyomavirus has been well-documented. However, until recently, the viral association has not been incorporated into therapy. In October 2025, researchers at Yale developed a vaccine derived from mRNA to induce an anti-tumor response in Merkel cell carcinoma. The novel vaccine is projected to be used as neoadjuvant or adjuvant treatment. The initial study found the vaccine to have higher efficacy in combination with PD-1 inhibitors which might change the treatment course of Merkel cell carcinoma as we know it.10

Dermoscopy

Dermoscopy enhances detection of low-grade non-melanoma skin cancers and can streamline same-day treatment. When there is high diagnostic certainty on dermoscopy, definitive treatment with excision can be performed prior to waiting for biopsy results. This concept is especially useful for patients who are elderly, live in rural settings, or struggle with lack of transportation. Interestingly, a recent study determined higher diagnostic accuracy of BCCs diagnosed by dermoscopy and later confirmed with pathology than lesions initially biopsied prior to treatment.11,12

Conclusion

The field of cutaneous malignancy is progressing at an accelerated rate, and there are no plans for it to slow down any time soon. Over the past year there have been hundreds of new publications with data for updated management pearls for non-melanoma skin cancer. The future appears full of possibilities. Hopefully patients will reap the benefits of these advancements.

 

References:

  1. Ciuciulete AR, Stepan AE, Andreiana BC, Simionescu CE. Non-Melanoma Skin Cancer: Statistical Associations between Clinical Parameters. Curr Health Sci J. 2022;48(1):110-115. doi:10.12865/CHSJ.48.01.16.
  2. Turner CW, Torgerson L. Modernizing U.S. Sunscreen Regulations: How Newer Filters Can Improve Public Health. Photodermatol Photoimmunol Photomed. 2025;41(5):e70032. doi:10.1111/phpp.70032.
  3. Department of Health and Human Services Food and Drug Adminstration. General and Plastic Surgery Devices: Restricted Sale, Distribution, and Use of Sunlamp Products; Withdrawal of Proposed Rule. March 16, 2026. https://www.federalregister.gov/documents/2026/03/16/2026-05103/general-and-plastic-surgery-devices-restricted-sale-distribution-and-use-of-sunlamp-products
  4. An S, Kim K, Moon S, et al. Indoor Tanning and the Risk of Overall and Early-Onset Melanoma and Non-Melanoma Skin Cancer: Systematic Review and Meta-Analysis. Cancers (Basel). 2021;13(23):5940. Published 2021 Nov 25. doi:10.3390/cancers13235940.
  5. Boudreaux B, Christensen H, Porter HJ, et al. Oncologic outcomes for invasive squamous cell carcinoma with a clinically resolved biopsy site managed by watchful waiting: A retrospective cohort study. J Am Acad Dermatol. 2025;92(4):801-806. doi:10.1016/j.jaad.2024.11.067.
  6. Schlesinger T, Chapman MS, Tu JH, et al. Red light photodynamic therapy with 10% aminolevulinic acid gel showed efficacy for treatment of superficial basal cell carcinoma in a randomized, vehicle controlled, double-blind, multicenter phase III study. J Am Acad Dermatol. 2025;93(6):1489-1498. doi:10.1016/j.jaad.2025.08.031.
  7. Migden M, Ibrahim Sherrif, et al. Intralesional Cemiplimab for Patients With Early-Stage Cutaneous Squamous Cell Carcinoma: Results From a Phase 1 Pilot Study Expansion Cohort. J of Skin. 2026;10(2):s755. doi:10.25251/8sr2bf52.
  8. Medicus Pharma. Medicus Pharma Reports Positive Phase 2 SKNJCT-003 Topline Data Observing 73% Clinical Clearance and 40% Histological Clearance (CR) at Day 57 in 200μg Cohort. March 5, 2026. https://medicuspharma.com/medicus-pharma-reports-positive-phase-2-sknjct-003-topline-data-observing-73-clinical-clearance-and-40-histological-clearance-cr-at-day-57-in-200g-cohort/.
  9. Rischin D, Porceddu S, Day F, et al. Adjuvant Cemiplimab or Placebo in High-Risk Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2025;393(8):774-785. doi:10.1056/NEJMoa2502449.
  10.  Frey A, Clulo K, Fei Y, Dumit TC, Scallo F, Allen JW, Chang E, Perry CJ, Wirth LV, Jacobs D, Braun DA, Bosenberg MW, Tran TT, Clune J, Kluger HM, Olino K, Ishizuka JJ. Targeting an essential viral oncoprotein with an IL-7-enhanced mRNA vaccine induces durable immunity to Merkel cell carcinoma. Cell Rep. 2025 Oct 28;44(10):116359. doi: 10.1016/j.celrep.2025.116359. Epub 2025 Oct 1. PMID: 41042672.
  11. Donoso F, Aguero R, Caussade MC, et al. Streamlined Management of Basal Cell Carcinoma with Dermoscopy: A Retrospective Case-Control Study. J Clin Med. 2025;14(24):8945. Published 2025 Dec 18. doi:10.3390/jcm14248945.
  12. Seiverling, E Vinny. Moving Beyond the Basics: The Role of Dermoscopy in Streamlining BCC Management. Presented at: The American Academy of Dermatology Annual Meeting Spring 2026. Denver, Colorado.


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