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
Outcome
Ameluz-PDT
Placebo-PDT
Primary endpoint achievement
66% (95 of 145)
5% (2 of 42)
Histological clearance
76%
19%
Complete clinical clearance
83%
21%
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.
