Clinical Report: Photodynamic therapy gains FDA approval for superficial BCC

Overview

The FDA has approved aminolevulinic acid hydrochloride (Ameluz) topical gel for use with photodynamic therapy in treating superficial basal cell carcinoma (BCC).

Background

Superficial basal cell carcinoma (BCC) is the most common skin cancer in the United States, with approximately 3.6 million cases diagnosed annually.

Data Highlights

Key Findings

• Ameluz is the first FDA-approved photodynamic therapy drug for skin cancer.
• 66% of patients treated with Ameluz achieved the primary endpoint compared to 5% with placebo.
• Histological clearance was observed in 76% of patients receiving Ameluz versus 19% for placebo.
• 83% of patients treated with Ameluz achieved complete clinical clearance of all target lesions compared to 21% for placebo.
• Application-site reactions were the most common adverse effects, consistent with the known safety profile of the therapy.

Clinical Implications

Clinicians should consider this therapy as part of the management plan for suitable patients.

Conclusion

The FDA's approval of Ameluz for superficial BCC represents a new treatment option for this common skin cancer.

Related Resources & Content

1. The ASCO Post, FDA Approves Topical Photodynamic Therapy for Superficial BCC, 2026 -- FDA Approves Topical Photodynamic Therapy for Superficial BCC
2. FDA Approves Topical Photodynamic Therapy for Superficial BCC - The ASCO Post, 2026 -- FDA Approves Topical Photodynamic Therapy for Superficial BCC
3. The ASCO Post — FDA Approves Topical Photodynamic Therapy for Superficial BCC
4. ophthalmology management — Integrating Photobiomodulation Into Retina Practice
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7. FDA Approves Topical Photodynamic Therapy for Superficial BCC - The ASCO Post
8. Approval Label_208081s040lbl.pdf
9. 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 - PubMed
10. NCCN CLINICAL PRACTICE GUIDELINES IN ONCOLOGY
11. Basal cell carcinoma clinical guideline
12. Frontiers | Efficacy and safety of ALA/MLA photodynamic therapy for superficial and nodular basal cell carcinoma: a systematic review and meta-analysis
13. Five-Year Results of a Randomized Controlled Trial Comparing Effectiveness of Photodynamic Therapy, Topical Imiquimod, and Topical 5-Fluorouracil in Patients with Superficial Basal Cell Carcinoma - PubMed