The U.S. Food and Drug Administration (FDA) has approved Biofrontera Inc.’s supplemental New Drug Application for Ameluz (aminolevulinic acid hydrochloride topical gel, 10%) in combination with photodynamic therapy using the BF-RhodoLED lamp series for the treatment of superficial basal cell carcinoma (sBCC) in adults.
The approval expands the use of Ameluz into skin cancer treatment and provides a nonsurgical option for adults with superficial basal cell carcinoma.
Ameluz Becomes First FDA-Approved PDT Drug for Skin Cancer
With the new approval, Ameluz is the first and only photodynamic therapy drug approved by the FDA for the treatment of a skin cancer.
It is also the only topical PDT in the United States indicated for both actinic keratosis (AK), a precancerous skin condition, and skin cancer.
Biofrontera plans to launch the sBCC indication between the fourth quarter of 2026 and the first quarter of 2027, using its existing commercial organization and installed lamp base.
Phase 3 Trial Supports the Approval
The approval was supported by a multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial involving 187 adults with histologically confirmed superficial basal cell carcinoma.
The primary endpoint measured both clinical and histological complete response of a main target lesion 12 weeks after the start of the final PDT cycle.
The endpoint was achieved by:
- 66% of patients treated with Ameluz PDT
- 5% of patients treated with placebo-PDT
Histological clearance of the main target lesion was observed in 76% of Ameluz-treated patients, compared with 19% of patients receiving placebo-PDT.
Ameluz-treated patients also achieved an 83% complete clinical clearance rate across all target lesions, compared with 21% with placebo-PDT.
The most common adverse reactions were application-site reactions consistent with the known safety profile of Ameluz PDT.
A Nonsurgical Option for sBCC
The approval adds another treatment approach for adults with superficial basal cell carcinoma, including patients with multiple lesions or lesions in cosmetically sensitive locations, as well as those for whom surgery may not be preferred.
M. Shane Chapman, MD, MBA, a dermatologist and professor at Dartmouth Hitchcock Medical Center and the Dartmouth Geisel School of Medicine, described the approval as an expansion of PDT for patients with superficial basal cell carcinoma.
The new indication brings Ameluz and the BF-RhodoLED platform further into dermatologic oncology, extending its use beyond actinic keratosis to the treatment of superficial basal cell carcinoma.
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References: The Derm Digest — “US FDA Approves Ameluz Red Light PDT for Superficial Basal Cell Carcinoma
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