Microneedle Cancer Treatment Earns FDA Meeting

An experimental skin cancer patch has reached a key regulatory step, with the FDA agreeing to meet with Medicus Pharma to discuss potentially fast-tracking development of its microneedle drug delivery system for basal cell carcinoma.

The company announced that more than three-quarters of patients have already been enrolled in its phase 2 trial testing the microneedle skin patch containing doxorubicin, a long-used chemotherapy. Medicus expects to hear back from the agency before the end of September on next steps, which could include moving more quickly toward pivotal testing.

The American Cancer Society estimates that about 5.4 million cases of basal and squamous cell skin cancers are diagnosed in the United States each year, with basal cell carcinoma making up roughly 80% of these cases. Although rarely fatal, it can cause serious local damage if untreated. Current standards of care rely heavily on surgery, most commonly excision or Mohs surgery, which cure the majority of patients but require specialized skills and can lead to scarring or disfigurement.

Anti-PD-1 drugs are often second-line treatment for more advanced cancers. An emerging regimen for hard-to-treat basal cell carcinoma includes targeted drugs such as Erivedge (vismodegib) and Odomzo (sonidegib) given before surgery, which can shrink tumors in 50% to 60% of patients but generally stop working within a year, according to a 2025 review in Archives of Dermatological Research.

Basal cell carcinoma represents a substantial market opportunity, with treatment revenue projected to nearly double from $5.5 billion last year to $10 billion by 2035 as an aging population and increased awareness drive demand for nonsurgical options. North America currently accounts for about 60% of global treatment revenue for the condition, though Asia-Pacific is projected to grow fastest as skin cancer awareness and healthcare access expand.

Medicus’ approach is designed to simplify treatment. The patch delivers chemotherapy directly into tumors through tiny needles that dissolve in the skin, potentially reaching higher drug concentrations at the cancer site while limiting exposure to the rest of the body. In a phase 1 study, 6 of 13 patients saw complete tumor clearance, and no serious safety problems were reported.

The current phase 2 study randomizes 90 patients across three groups: placebo, low-dose and high-dose. An interim analysis in half of the participating patients showed more than 60% clinical clearance, prompting the investigational review board to expand their original enrollment target.

Success in the FDA discussions could position Medicus to convert its exploratory phase 2 trial into a pivotal study, potentially shortening the path to market approval. The company expects to complete enrollment in its primary study by year-end, with initial efficacy data anticipated in 2026.

A 2025 review in Pharmaceutics reports that microneedle patches have drawn significant interest in recent years, moving beyond diabetes and vaccines into cancer applications. Researchers highlight that the devices can bypass the skin’s natural barrier to deliver drugs directly into tumors, with potential to reduce systemic toxicity and help overcome treatment resistance. To date, most FDA-cleared microneedle products are limited to vaccines and dermatology uses such as cosmetic applications. None have yet been approved for oncology.

ClinicalTrials.gov lists 15 ongoing microneedle studies, including two in cancer beyond basal cell carcinoma. One is testing a microneedle array plus doxorubicin in cutaneous squamous cell carcinoma, while another explores a vaccine candidate, Modi-1, delivered via microneedles in breast, head and neck, ovarian, and renal cancers. Both remain in early-phase recruitment.