FDA Approves Aminolevulinic Acid Gel With PDT for Superficial Basal Cell Carcinoma

The FDA has approved aminolevulinic acid (ALA) hydrochloride topical gel, 10% (Ameluz), in combination with photodynamic therapy (PDT) using the BF-RhodoLED lamp series, for the treatment of superficial basal cell carcinoma (sBCC) in adults.¹

The approval makes ALA gel the first and only PDT drug approved by the FDA for a skin cancer, and the only topical PDT in the United States indicated for both a precancerous condition, actinic keratosis, and a skin cancer.

“FDA approval of [ALA gel] for superficial basal cell carcinoma is a defining milestone for Biofrontera,” said Hermann Luebbert, PhD, chief executive officer and chairman of Biofrontera, in a news release, adding that it provides dermatologists an “effective, nonsurgical option” for a common skin cancer.

Efficacy Data Supporting Approval

The approval was supported by the multicenter, randomized, double-blind, vehicle-controlled phase 3 ALA-BCC-CT013 trial (NCT03573401), which enrolled 187 adults with histologically confirmed sBCC randomly assigned 4:1 to receive ALA gel or vehicle PDT for 1 or 2 cycles.²

The primary end point was a composite of clinical and histological complete response of a main target lesion at 12 weeks after the start of the final PDT cycle. This end point was met by approximately 66% of patients treated with ALA gel PDT (95 of 145) compared with 5% of those treated with placebo-PDT (2 of 42).

Histological clearance of the main target lesion occurred in 76% of ALA gel PDT-treated patients vs 19% with placebo-PDT, and 83% of ALA gel–treated patients achieved complete clinical clearance of all target lesions compared with 21% with placebo-PDT. For 89.3% of lesions treated with the topical gel, aesthetic outcome was rated very good or good, compared with 58.0% of lesions treated with placebo, according to the trial's published results.

Safety Findings

The most common adverse reactions were application-site reactions consistent with the known safety profile. According to the trial's published results, 1024 treatment-emergent adverse events (TEAEs) possibly related to treatment occurred in the experimental arm, of which 62.4% were mild, 31.0% were moderate, and 6.2% were severe; no TEAEs led to treatment discontinuation. TEAEs occurred at the application site and included pain, erythema, pruritus, edema, paresthesia, scab, and exfoliation, with the most frequent events having a median duration of 1 week or less.

Disease Background

BCC is the most common skin cancer in the United States, with approximately 3.6 million cases diagnosed annually; superficial BCC makes up approximately 15% to 20% of BCC cases. Superficial lesions can measure up to several centimeters in diameter, are frequently located on the trunk and extremities, and often present as multiple lesions, for which non-surgical, tissue-sparing treatment options have been limited.¹

“For many patients with superficial basal cell carcinoma—those with multiple lesions, lesions in cosmetically sensitive locations, or for whom surgery would not be preferred—treatment options have been limited,” said M. Shane Chapman, MD, MBA, professor and founding chair of the Department of Dermatology at Dartmouth Hitchcock Medical Center and the Dartmouth Geisel School of Medicine, and a contributor to the phase 3 trial, in the news release. “This FDA approval for [ALA gel] and the RhodoLED gives us a rigorously studied, non-surgical option that we can deliver in our office.”

The new indication uses the same topical product and red-light device as the topical gel’s existing actinic keratosis indication. According to the company, Biofrontera is planning an official launch of the sBCC indication in late in the fourth quarter of 2026 through the first quarter of 2027, using its existing commercial organization and installed lamp base. Separately, a phase 3 study evaluating this therapy for squamous cell carcinoma in situ is reported to be in preparation, according to the company's product pipeline.

REFERENCES

1. Biofrontera Announces FDA Approval of Aminolevulinic acid hydrochloride ® Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma. News release. Biofrontera Inc. September 14, 2026. Accessed September 14, 2026. https://tinyurl.com/3zavpt5x

2. Schlesinger T, Chapman MS, Tu JH, et al. Red light photodynamic therapy with 10% aminolevulinic acid gel showed efficacy for treatment of superficial basal cell carcinoma in a randomized, vehicle controlled, double-blind, multicenter phase III study. J Am Acad Dermatol. 2025;93(6):1489-1498. doi:10.1016/j.jaad.2025.08.031