FDA Approves Ameluz PDT for Superficial Basal Cell Carcinoma
Key Takeaways
- The FDA approved Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, with BF-RhodoLED photodynamic therapy (PDT) for superficial basal cell carcinoma (sBCC) in adults.
- In the phase 3 trial supporting approval, 66% of patients treated with Ameluz PDT achieved the composite primary endpoint of clinical and histological complete response of the main target lesion, compared with 5% receiving vehicle-PDT.
- The new indication provides a nonsurgical treatment option using the same Ameluz formulation and BF-RhodoLED lamp series already used for actinic keratosis.
The US 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 (PDT) using the BF-RhodoLED lamp series for the treatment of superficial basal cell carcinoma (sBCC) in adults.
According to Biofrontera, the expanded indication makes Ameluz the first PDT drug approved by the FDA to treat a skin cancer. Ameluz PDT is also indicated for actinic keratosis.
Phase 3 Trial Supports Ameluz Approval for Superficial BCC
The approval was supported by a multicenter, randomized, double-blind, vehicle-controlled phase 3 trial involving 187 adults with histologically confirmed sBCC. The primary endpoint was clinical and histological complete response of a main target lesion 12 weeks after initiation of the final PDT cycle.
The composite endpoint was achieved by 66% of patients receiving Ameluz PDT (95/145), compared with 5% receiving vehicle-PDT (2/42). Histological clearance of the main target lesion occurred in 76% of Ameluz-treated patients versus 19% of controls. Complete clinical clearance of all target lesions was reported in 83% and 21%, respectively.
The most common adverse reactions were application-site reactions, according to Biofrontera.
“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, MBA, a board-certified dermatologist and professor and founding chair of the Department of Dermatology at Dartmouth Hitchcock Medical Center and the Dartmouth Geisel School of Medicine. “This FDA approval for Ameluz and the RhodoLED gives us a rigorously studied, non-surgical option that we can deliver in our office.”