The US Food and Drug Administration approved aminolevulinic acid hydrochloride (Ameluz) topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED lamp series for adults with superficial basal cell carcinoma, according to a Biofrontera press release.
The approval expands the indication for aminolevulinic acid hydrochloride, which is also indicated for actinic keratosis. According to Biofrontera, Ameluz is the first and only photodynamic therapy drug approved by the FDA for skin cancer treatment.
Approximately 3.6 million cases of basal cell carcinoma (BCC), the most common US skin cancer, are diagnosed each year, according to Skin Cancer Foundation figures cited by Biofrontera. Biofrontera cited published estimates placing superficial disease at 15% to 20% of BCC cases, or approximately 540,000 to 720,000 US cases each year. The release noted that superficial BCC may involve multiple lesions, commonly affecting the trunk and extremities.
Supporting data came from a phase 3 trial that enrolled 187 adults with histologically confirmed superficial BCC and used a multicenter, randomized, double-blind, vehicle-controlled design. Researchers assessed the main target lesion for both clinical and histological complete response at 12 weeks following initiation of the final photodynamic therapy cycle; achievement of both constituted the primary end point.
The primary end point was achieved by 95 of 145 patients (66%) treated with aminolevulinic acid hydrochloride photodynamic therapy compared with 2 of 42 patients (5%) receiving placebo photodynamic therapy.
Histological clearance of the main target lesion occurred in 76% of patients treated with aminolevulinic acid hydrochloride compared with 19% receiving placebo photodynamic therapy. Complete clinical clearance of all target lesions occurred in 83% of patients receiving aminolevulinic acid hydrochloride compared with 21% receiving placebo photodynamic therapy.
Biofrontera reported that application-site reactions were the most frequently observed adverse reactions and described them as consistent with the therapy’s known safety profile.
“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, board certified dermatologist, Professor and Founding Chair, Department of Dermatology of Dartmouth Hitchcock Medical Center and the Dartmouth Geisel School of Medicine, who contributed to the phase 3 study.
Source: Biofrontera
