Nonsurgical Skin Cancer Care and New Approvals, With Todd Schlesinger, MD

Nonsurgical and systemic options for keratinocyte carcinoma have expanded over the past year, giving dermatologists more ways to manage lesions outside the operating room. In September 2026, the US Food and Drug Administration (FDA) approved aminolevulinic acid hydrochloride 10% gel (Ameluz; Biofrontera) with red light photodynamic therapy (PDT) for superficial basal cell carcinoma. It is the first PDT approval for a skin cancer.¹

In the supporting phase 3 trial, 66% (95/145) of patients treated with Ameluz-PDT achieved composite clinical and histological complete response at 12 weeks, compared with 5% (2/42) receiving placebo-PDT.¹ Histological clearance reached 76% with active treatment vs 19% with placebo.¹

For high-risk cutaneous squamous cell carcinoma, the FDA approved cemiplimab (Libtayo; Regeneron) in October 2025 as adjuvant treatment following surgery and radiation. In the C-POST trial (N = 415), cemiplimab reduced the risk of disease recurrence or death by 68% vs placebo (HR, 0.32; 95% CI, 0.20-0.51; P < .0001).²

Advances extend beyond oncology. In October 2026, the FDA approved remibrutinib (Rhapsido; Novartis), an oral Bruton tyrosine kinase inhibitor, for adults with symptomatic dermographism inadequately controlled by H1 antihistamines, expanding its label beyond chronic spontaneous urticaria.³ In the symptomatic dermographism cohort of the phase 3 RemIND trial, 29.3% of patients receiving remibrutinib achieved complete hive response at week 12 vs 14.0% receiving placebo (P = .0229), according to Novartis.³

Todd Schlesinger, MD, is a board-certified dermatologist and Mohs surgeon and director of the Clinical Research Center of the Carolinas in Charleston, South Carolina. In the following interview, Schlesinger spoke with HCPLive at the 2026 Fall Clinical Dermatology Conference in Las Vegas about these approvals, emerging nonsurgical skin cancer therapies, exosome research, and his center’s ongoing trials:

HCPLive: What are 2 or 3 highlights in nonmelanoma skin cancer clinicians should know about?

Todd Schlesinger, MD: Nonmelanoma skin cancer is a very exciting area for us right now. I think the number 1 highlight is we now have approval for PDT, photodynamic therapy, with Ameluz for the management of superficial basal cell carcinoma. This was just recently approved on September 9. It’s based on a study we did, which I was lead author on, published…in January. So now we can use photodynamic therapy with red light, a 3-hour incubation, and 2 to 4 cycles to treat superficial basal cell carcinoma pretty much anywhere on the body. The label was nice and open, so that gives us options to treat with PDT. That’s number 1.

Number 2 is the option of using adjuvant immunotherapy, cemiplimab, after surgery and radiation for patients with advanced or locally advanced squamous cell carcinoma who are high risk. They have certain high-risk factors, like perineural invasion, multiple lymph nodes, or deep invasion of the tumor. That has been a new adoption for us in skin cancer.

Number 3 is the idea of using sequential therapies to treat actinic keratoses: sequential PDT, sequential tirbanibulin, or other topicals we use to treat actinic keratosis. The key is actinic keratosis is a chronic condition requiring ongoing management, so it’s important to maybe even set your patients up for twice-a-year photodynamic therapy. With tirbanibulin, for example, you can repeat the therapy. The label doesn’t support it, since the label is 1 time, as in the studies, but many people may be doing it twice a year as well. Many folks also like using imiquimod and 5-FU, the old standards for actinic keratosis.

So those are the 3 main things going on. We also have a new medication out, a PD-L1 inhibitor called cosibelimab, which is approved for the management of locally advanced and metastatic cutaneous squamous cell carcinoma. It’s an IV, as is cemiplimab. And of course, pembrolizumab is still approved as well, so we have 3 therapies. Pretty exciting times.

HCPLive: What were your highlights from your session on skin cancer management beyond the knife?

Todd Schlesinger, MD: Beyond the knife, we talked about nonsurgical interventions for skin cancer. Number 1 is the approval for superficial basal cell carcinoma. Number 2, there are pulsed energy devices out there in the wings that may do very nicely to treat basal cell carcinoma. There are also intralesional therapies: one being an oncolytic peptide, another being a shuttle peptide. And there are some new mechanisms of action coming along as well. There’s an intralesional immunotherapy study being done…right now at our study site and others. So those are new things. I think we’ll see a lot more new companies coming in to give us options for the nonsurgical management of not only basal cell carcinoma but also squamous cell carcinoma, and even melanoma, Merkel cell carcinoma, and others. The innovation in the pipeline for skin cancer is very high.

HCPLive: What are the key takeaways from your EADV presentation on exosomes?

Todd Schlesinger, MD: Every year at EADV, I try to bring the latest 2025 and 2026 information on exosomes. Some of the new developments are new ways to isolate them and get more purity. Companies are now focused on the effect of the exosomes, and the contents of exosomes can now be better characterized. Some companies are coming into our world with INDs, investigational new drugs, aimed at hair or other areas where exosomes could, in the future, be injected as an approved drug. Right now, there are no approved exosome therapies in the United States or most of the world. Mostly, people are using them as topicals, as an adjunct topical, sort of a cosmetic. But as we go down the road, I think we’ll see more of a regulatory pathway through the FDA, the EMA, and other regulatory bodies around the world, so exosomes can hopefully become an approved medication. So that is coming.

HCPLive: How does remibrutinib’s new approval help patients who previously had limited treatment options?

Todd Schlesinger, MD: Remibrutinib is approved for chronic spontaneous urticaria and symptomatic dermographism. We do not have approval yet for chronic inducible urticaria; that hopefully is coming in the future, and it will be big for us. Symptomatic dermographism is the label update, which came really this week, and it’s very exciting. It brings another level of care we can use with remibrutinib, and it means people need to start thinking about how we identify patients with symptomatic dermographism in the clinic. Are you testing for it? Are you asking patients questions? Are you trying to elicit dermographism on the patient’s skin in different ways? It brings a new option for treating those patients. And for chronic spontaneous urticaria, we’re already seeing good successes in patients who have failed second-generation H1 antihistamines, bringing them more relief from the itching and hives they had before. So these are exciting times, and of course there are new developments coming out in that area as well.

HCPLive: What current research would you like to highlight for your colleagues?

Todd Schlesinger, MD: My trial center is currently working on HS, hidradenitis suppurativa, quite a bit, with a couple of new pathways, IL-1 being one and BTK being another. We’re working on the intralesional…studies for cutaneous squamous cell carcinoma, and there are a number of new extended half-life medications coming out for psoriasis and atopic dermatitis as well.

We actually just finished and published a couple of studies on patients with fragile skin, or dermatoporosis. We did a bruising study with a good friend of mine, Glynis Ablon, out of California. She and I did studies showing some nice benefits for one of the topical skincare products…with good outcomes for reducing bruising in patients using the topical cream, and we also looked at the biomarker changes. That’s one exciting one.

We also just completed a cosmetic study of tirbanibulin, looking at that actinic keratosis treatment and getting some nice images with high-level…imaging, showing improvement not only in the actinic keratoses but also the cosmetic benefit. I showed a few of those cases a few weeks ago at a meeting here in the United States, and we will hopefully have several abstracts accepted at AAD next year, with papers to follow. So, stay tuned.

Editor’s Note: This transcript has been edited for grammar and clarity using artificial intelligence tools.

References

1. Smith T. Ameluz treatment becomes first FDA-approved PDT for skin cancer. HCPLive. Published September 14, 2026. Accessed October 20, 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 20, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma.

3. Novartis. Novartis Rhapsido (remibrutinib) receives FDA approval as first treatment for symptomatic dermographism (SD), expanding its use beyond chronic spontaneous urticaria (CSU). Published October 7, 2026. Accessed October 20, 2026. https://www.novartis.com/news/media-releases/novartis-rhapsido-remibrutinib-receives-fda-approval-first-treatment-symptomatic-dermographism-sd-expanding-its-use-beyond-chronic-spontaneous-urticaria-csu.