Photodynamic therapy gains FDA approval for superficial BCC

Phase 3 trial data showed greater clinical and histological clearance than with placebo photodynamic therapy.

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The FDA approved aminolevulinic acid hydrochloride (Ameluz) for use with photodynamic therapy for superficial basal cell carcinoma.
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Ameluz is the first FDA-approved photodynamic therapy drug specifically for skin cancer treatment.
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Superficial basal cell carcinoma accounts for approximately 15% to 20% of the 3.6 million BCC cases diagnosed annually in the US.
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In a phase 3 trial, 66% of patients treated with Ameluz achieved the primary endpoint compared to 5% in the placebo group.
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Application-site reactions were the most common adverse effects noted, aligning with the therapy's known safety profile.

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