This week, the US Food and Drug Administration (FDA) approved Biofrontera's supplemental new drug application (sNDA) for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, implemented with the BF-RhodoLED lamp series, for the treatment of superficial basal cell carcinoma (sBCC) in adults, making it the first photodynamic therapy (PDT) regimen the agency has cleared for a skin cancer.¹
Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research in San Diego and chief medical editor of Practical Dermatology, discussed the September 14 approval with HCPLive. Bhatia was asked about both the approval’s significance and some of the data surrounding the decision.
The approval, granted a decade after Ameluz's original actinic keratosis (AK) indication, makes it the only topical PDT in the United States indicated for both a precancerous lesion and a skin malignancy.¹ It was supported by a multicenter, randomized, double-blind, vehicle-controlled phase 3 trial in 187 adults with histologically confirmed sBCC, in which 66% of patients treated with Ameluz PDT (95 of 145) achieved complete clinical and histological response of the main target lesion at 12 weeks, compared with 5% (2 of 42) on placebo-PDT.¹ HCPLive's full report on the approval covers the regulatory background and trial data in more depth.²
"I don't want to ever say best option, but the easiest option,” Bhatia said. “People on anticoagulants, people on oxygen, there's always ways to think about, OK, where can I use something that doesn't involve surgery but still has efficacy of the tumor clearance? And I think this is where now we have a really good option in front of us.”
Bhatia said the indication gives dermatologists another nonsurgical route for patients whose lesions sit in difficult-to-treat locations, such as the pretibial surfaces, behind the ears, or near the eyelids, or who are poor surgical candidates because of anticoagulant or oxygen therapy. Mohs surgery remains the gold standard, he noted, alongside established options such as electrodesiccation and curettage and topical imiquimod.
He noted red-light PDT also treats the photo-damaged skin surrounding a tumor in addition to the lesion itself, a field effect he sees as an added benefit over surgical excision alone. Bhatia said he expects photodynamic therapy, delivered through the smaller BF-RhodoLED unit or the larger panel light, to become a standard fixture across dermatology practice settings.
Editor’s note: This transcript has been edited for grammar and clarity using artificial intelligence tools.
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