What’s New in Nonsurgical Skin Cancer Care, With Todd Schlesinger, MD

Dermatologists have a growing set of tools for treating keratinocyte carcinoma outside the operating room. During the 2026 Fall Clinical Dermatology Conference in Las Vegas, Nevada, Todd Schlesinger, MD, a Mohs surgeon and director of the Clinical Research Center of the Carolinas, spoke with HCPLive’s team about the developments he considers most relevant to practice.

What Did the FDA Approve for Superficial Basal Cell Carcinoma (sBCC)?

Foremost was the September 2026 US Food and Drug Administration (FDA) approval of aminolevulinic acid hydrochloride 10% gel (Ameluz; Biofrontera) with red light photodynamic therapy (PDT) for superficial basal cell carcinoma, the first PDT approval for any skin cancer. Schlesinger, lead author of the pivotal study, noted the protocol involves a 3-hour incubation and 2 to 4 cycles, with no anatomic site restriction on the label. In the phase 3 trial, 66% of actively treated patients achieved composite complete response at week 12 vs 5% with placebo-PDT.

He also highlighted adjuvant cemiplimab (Libtayo; Regeneron), approved in October 2025 for high-risk cutaneous squamous cell carcinoma after surgery and radiation, particularly in patients with perineural invasion, multiple nodal metastases, or deep invasion. In the 415-patient C-POST trial, it cut the risk of recurrence or death by 68% vs placebo (HR, 0.32). Cosibelimab, a PD-L1 inhibitor, and pembrolizumab round out 3 intravenous options for advanced disease.

Because actinic keratosis is chronic, Schlesinger recommends scheduled, repeated field therapy, such as PDT twice yearly. Some clinicians retreat with tirbanibulin despite its single-course labeling, and imiquimod and fluorouracil remain mainstays.

What Nonsurgical Skin Cancer Therapies Are in Development?

Schlesinger pointed to a crowded pipeline: pulsed energy devices for basal cell carcinoma, intralesional oncolytic and shuttle peptides, and an intralesional immunotherapy under study at his site. He expects nonsurgical options to expand to squamous cell carcinoma, melanoma, and Merkel cell carcinoma.

Where Does Exosome Research Stand?

Reviewing his 2026 European Academy of Dermatology and Venereology Congress presentation, he said refined isolation techniques are producing purer exosome preparations with better-defined contents, and some companies have filed investigational new drug applications for indications such as hair loss. No exosome therapy is approved in the US, and current use is mostly as a cosmetic topical adjunct, but he anticipates clearer FDA and EMA pathways ahead.

Editor’s Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Schlesinger reported no relevant financial disclosures.

References

1. Smith T. Ameluz treatment becomes first FDA-approved PDT for skin cancer. HCPLive. Published September 14, 2026. Accessed October 23, 2026. https://www.hcplive.com/view/ameluz-treatment-becomes-first-fda-approved-pdt-skin-cancer.

2. US Food and Drug Administration. FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma. Published October 8, 2025. Accessed October 23, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma.