News|Articles|September 17, 2026

Q&A: What the First FDA-Approved PDT for Skin Cancer Means for sBCC Care

Fact checked by: Tim Smith

Neal Bhatia, MD, weighs the newly approved Ameluz PDT regimen for sBCC against Mohs surgery, citing its 66% composite response rate.

Biofrontera's Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, paired with the BF-RhodoLED lamp series, has received an approval by the US Food and Drug Administration (FDA) approval for superficial basal cell carcinoma (sBCC) in adults.¹ The approval makes photodynamic therapy (PDT) the first modality of its kind cleared to treat a skin cancer in the US.¹˒²

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