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:
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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/.
- 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.
- 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.
- 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.
- 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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