Melanoma Monday 2026: Rising Incidence Meets New Innovations in Prevention, Detection, and Treatment

Skin cancer is America's most common cancer, with an estimated 5.4 million cases diagnosed in the country each year. In 2026 alone, the American Cancer Society projects new melanoma diagnoses will rise 10.6%, totaling 234,680 cases across the US. About 112,000 cases are expected to be invasive, with more than 8,500 deaths expected from the disease.¹

As Melanoma Monday kicks off May's Skin Cancer Awareness Month, Dermatology Times is spotlighting emerging data, evolving tools, and public health initiatives reshaping how dermatology clinicians can approach prevention, detection, and survivorship.

Genomic Testing Refines SLNB Decisions

One of the more practice-changing tools involves the DecisionDx-Melanoma gene expression profile (GEP) test, developed by Castle Biosciences. The test has shown superiority over both traditional staging systems and competing molecular models in identifying which melanoma patients have a low risk of sentinel lymph node (SLN) metastasis and may safely forgo sentinel lymph node biopsy (SLNB).

A recent expert consensus review published in the Dermatology Online Journal provides strong backing for integrating the 31-GEP test into routine melanoma management.² The review was conducted by 10 board-certified dermatologists specializing in melanoma, who performed a comprehensive literature search identifying 26 eligible articles encompassing more than 7,500 patients. The panel noted that integration of the 31-GEP test with AJCC8 staging significantly improves prognosis assessment and informs sentinel lymph node biopsy decisions, and that the test provides personalized risk assessments that are especially useful when traditional clinicopathologic factors are unknown or ambiguous.

“We made a number of recommendations as to how the 31-GEP test can refine care for our patients with melanoma; the idea being that personalized risk assessments can refine the care for our melanoma patients. When we can predict how an individual melanoma will behave, we can offer individualized medicine," David Cotter, MD, PhD, board-certified dermatologist at Las Vegas Dermatology in Nevada and expert panel member, told Dermatology Times.

Pipeline Updates in Melanoma and Beyond

In melanoma, a new phase 1b/2 trial has launched evaluating a novel approach to disrupting polyamine metabolism. Aminex Therapeutics has initiated a multicenter, open-label trial of AMXT 1501—a polyamine transport inhibitor—in combination with difluoromethylornithine (DFMO) in patients with metastatic melanoma and in women with advanced breast cancer.³ The approach is designed to block the polyamine pathway, which tumors rely on to proliferate and suppress immune responses, and the melanoma cohort will receive the combination alongside pembrolizumab.

On the cutaneous squamous cell carcinoma front (cSCC), cosibelimab-ipdl (UNLOXCYT), a novel anti–PD-L1 monoclonal antibody, for patients who are not candidates for curative surgery or radiation, recently became available in the US.⁴ Alpha Tau Medical has also submitted the first module of its pre-market approval (PMA) application to the FDA for Alpha DaRT, which currently has Breakthrough Device Designation for recurrent disease.⁵ In parallel, the ongoing ReSTART pivotal trial is evaluating Alpha DaRT in approximately 86 patients with recurrent cSCC.

For basal cell carcinoma (BCC), the FDA has accepted a supplemental new drug application for aminolevulinic acid hydrochloride 10% topical gel (Ameluz) used in combination with the Biofrontera RhodoLED red-light lamp series for patients with superficial BCC, with a PDUFA goal date of September 28, 2026.⁶ If approved, it would be the first US PDT photosensitizer indicated for sBCC. Meanwhile, Medicus Pharma has filed for FDA Orphan Drug Designation for SkinJect (D-MNA) in Gorlin Syndrome.⁷ SkinJect is a doxorubicin-containing dissolvable microneedle array designed for direct intradermal delivery into BCC lesions.

Expanding Prevention and Early Detection Efforts

Raising awareness around melanoma remains a central priority each May, particularly as incidence continues to rise alongside cumulative ultraviolet exposure—still the primary environmental driver of disease. Recently, we spoke with Olympic skier and melanoma patient, Travis Ganong, who highlighted a persistent gap in patient understanding of year-round risk, particularly in snow sport communities where altitude and snow reflectivity can amplify UV exposure and effectively double dose intensity.

Community-based initiatives, such as the Sun Bus, illustrate how outreach can bridge gaps in access by bringing full-body skin exams and prevention education directly to underserved populations. Mobile screening programs like these have already delivered tens of thousands of exams nationwide. Diagnostic, user-friendly frameworks like the ABCDE method, coined by Darrell Rigel, MD, MS; Robert Friedman, MD; and Alfred Kopf, MD, continue to support early detection as one of the most impactful tools in reducing melanoma mortality.

Join Dermatology Times all month long for the latest insights and perspectives as we celebrate Skin Cancer Awareness Month. Is there something you’d like to share with our readers? Connect with us on our social media or email us at [email protected].

References

1. American Cancer Society. Cancer Facts & Figures 2026. Atlanta: American Cancer Society; 2026. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2026/2026-cancer-facts-and-figures.pdf

2. Burshtein J, Cockerell C, Cotter D, et al. 31-gene expression profiling for cutaneous melanoma: An expert consensus panel. Dermatology Online Journal. 2025;31(5). doi:10.25251/c81v6j23

3. Aminex Therapeutics announces multiple sites activated for phase 1b/2 clinical trial of novel investigational cancer treatment AMXT 1501 and DFMO in patients with solid tumors including primarily breast cancer and melanoma. News release. Aminex Therapeutics. February 4, 2026. Accessed May 4, 2026. https://aminextx.com/wp-content/uploads/2026/02/FINAL-Aminex-Phase-1_2-Trial-Initiation-PR_.pdf

4. Sun Pharma Announces the Availability of UNLOXCYT™ (cosibelimab-ipdl) for Advanced Cutaneous Squamous Cell Carcinoma (aCSCC). News release. PR Newswire. Published January 15, 2026. Accessed May 4, 2026. https://www.prnewswire.com/news-releases/sun-pharma-announces-the-availability-of-unloxcyt-cosibelimab-ipdl-for-advanced-cutaneous-squamous-cell-carcinoma-acscc-302662801.html

5. Alpha Tau submits first pre-market approval module to the FDA for Alpha DaRT for the treatment of recurrent cutaneous squamous cell carcinoma (cSCC). News release. Alpha Tau Medical. January 5, 2026. Accessed May 4, 2026. https://www.alphatau.com/single-post/alpha-tau-submits-first-pre-market-approval-module-to-the-fda-for-alpha-dart-for-the-treatment-of-r

6. Biofrontera announces FDA filing acceptance of supplemental new drug application for Ameluz PDT in superficial basal cell carcinoma. News release. Biofrontera. February 11, 2026. Accessed May 4, 2026. https://www.biospace.com/press-releases/biofrontera-announces-fda-filing-acceptance-of-supplemental-new-drug-application-for-ameluz-pdt-in-superficial-basal-cell-carcinoma

7. Medicus Pharma submits orphan drug designation application to US FDA for SkinJect in Gorlin syndrome. News release. Medicus Pharma. April 17, 2026. Accessed May 4, 2026. https://www.globenewswire.com/news-release/2026/04/17/3276088/0/en/Medicus-Pharma-Submits-Orphan-Drug-Designation-Application-to-U-S-FDA-for-SkinJect-in-Gorlin-Syndrome.html