FDA Approves Biofrontera's Ameluz Red-Light PDT for Superficial Basal Cell Carcinoma
核心洞察
The FDA approved Biofrontera's supplemental New Drug Application for Ameluz topical gel 10% with the BF-RhodoLED (搜索) lamp for superficial basal cell carcinoma (搜索) in adults.
Ameluz becomes the first and only photodynamic therapy approved in the United States to treat a skin cancer, and the only topical PDT indicated for both actinic keratosis (搜索) and a skin cancer.
In a Phase 3 trial of 187 adults, 66% of Ameluz PDT patients achieved composite clinical and histological complete response versus 5% with placebo-PDT.
The U.S. Food and Drug Administration (搜索) has approved Biofrontera Inc.'s supplemental New Drug Application for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, used in combination with photodynamic therapy (PDT) delivered by the BF-RhodoLED (搜索) lamp series, for the treatment of superficial basal cell carcinoma (搜索) (sBCC) in adults. The approval, announced September 14, 2026, makes Ameluz the first and only PDT drug approved by the FDA to treat a skin cancer, and the only topical PDT in the United States indicated for both a pre-cancerous skin condition, actinic keratosis (搜索) (AK), and a skin cancer.
"This approval reflects years of disciplined investment in the clinical development of Ameluz, and the latest stage in the ongoing expansion of our PDT platform," said Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, who called the sBCC approval "a defining milestone" for the company.
A Common Tumor With Limited Non-Surgical Options
Basal cell carcinoma (搜索) is the most common skin cancer in the United States, with approximately 3.6 million cases diagnosed annually, according to the Skin Cancer Foundation. Published estimates cited by the company suggest the superficial subtype accounts for approximately 15% to 20% of BCC cases, or an estimated 540,000 to 720,000 sBCC cases annually in the U.S.
Superficial BCC lesions can be up to several centimeters in diameter and are frequently located on the trunk and extremities, often presenting as multiple lesions. According to the source materials, non-surgical, tissue-sparing treatment options for these patients are limited.
"For many patients with superficial basal cell carcinoma (搜索) — those with multiple lesions, lesions in cosmetically sensitive locations, or for whom surgery would not be preferred — treatment options have been limited," said Dr. M. Shane Chapman, MBA, board certified dermatologist, Professor and Founding Chair of the Department of Dermatology at Dartmouth Hitchcock Medical Center and the Dartmouth Geisel School of Medicine, and a key contributor to the Phase 3 study. "This FDA approval for Ameluz and the RhodoLED gives us a rigorously studied, non-surgical option that we can deliver in our office."
Phase 3 Efficacy and Safety Data
The approval is supported by a multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial in 187 adults with histologically confirmed sBCC. The primary endpoint was a composite of both clinical and histological complete response of a main target lesion 12 weeks after the start of the last PDT cycle.
That composite endpoint was achieved in 66% of subjects treated with Ameluz PDT (95/145), compared with 5% of subjects treated with placebo-PDT (2/42). Histological clearance of the main target lesion was observed in 76% of Ameluz PDT-treated patients versus 19% with placebo-PDT, and 83% of Ameluz-treated subjects achieved complete clinical clearance of all target lesions compared with 21% for placebo-PDT.
The most common adverse reactions were application-site reactions consistent with the known safety profile of Ameluz PDT.
Commercial Rollout and Platform Strategy
Because the new indication uses the same topical product and the same red-light device as the company's existing AK indication, Biofrontera expects existing customers to be able to rapidly adopt the new treatment option. The company said it is planning an official launch of the sBCC indication late in the fourth quarter of 2026 through the first quarter of 2027, leveraging its existing commercial organization and installed lamp base.
"We believe the approval represents a further driver of long-term growth for our existing customers. It also gives new Dermatology practices a reason to purchase a RhodoLED lamp and begin to use Ameluz PDT, expanding our overall installed base," Luebbert said.
Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with photodynamic therapy. Its products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, and superficial basal cell carcinoma (搜索), and are in development for additional indications.