Ameluz PDT cleared for superficial basal cell carcinoma

What this means

Superficial basal cell carcinoma (sBCC) is the most common form of skin cancer in the United States, with roughly 3.6 million BCC cases diagnosed each year and superficial BCC accounting for about 15-20 percent of them. Ameluz is Biofrontera's photodynamic-therapy gel that contains aminolevulinic acid, a natural precursor the skin converts into a photosensitizer inside the cancer cells; the BF-RhodoLED® red-light lamp is then shone on the lesion, activating the photosensitizer and selectively destroying the tumor cells while sparing normal skin. On Sept 14, 2026 the FDA approved a supplemental application (sNDA) that expands Ameluz's use from actinic keratosis to adults with superficial basal cell carcinoma, making Ameluz the first and only FDA-approved photodynamic therapy for a skin-cancer indication. In the pivotal Phase 3 trial of 187 adults with histologically confirmed sBCC (145 Ameluz-PDT vs 42 placebo-PDT), 66 percent of Ameluz-PDT patients met the primary composite endpoint of clinical and histological complete response of a main target lesion 12 weeks after the last PDT cycle, versus 5 percent for placebo-PDT; on the secondary measure of clinical clearance of all target lesions, the rates were 83 percent versus 21 percent. Biofrontera plans to launch the sBCC indication between late Q4 2026 and Q1 2027.