FDA Accepts sNDA for Aminolevulinic Acid Gel in Superficial Basal Cell Carcinoma

The FDA has accepted a supplemental new drug application for aminolevulinic acid hydrochloride (Ameluz) plus RhodoLED red light lamp series for patients with superficial basal cell carcinoma. A Prescription Drug User Fee Act date of September 28, 2026, has been set by the FDA. The FDA acknowledged no filing deficiencies in the sNDA.

A phase 3 trial (NCT03573401) assessed 145 patients with photodynamic therapy (PDT) plus 10% aminolevulinic acid (ALA) gel versus 42 patients who received PDT plus a vehicle. The median age at inclusion was 64 years, 58.3% of patients were male, and 100% were White. The location of the main target lesion included 2.1% on the face/scalp, 52.4% on the neck/trunk, and 45.5% on the extremities.

The primary end point was the composite clinical and histological clearance of main target lesions at the histological or clinical assessment. After the last cycle of PDT, the clearance rates of the main target lesions were 83.4% with the gel and 21.4% with the vehicle (P < .0001). Histological clearance was 75.9% for the gel and 19.0% for the vehicle (P < .0001). The composite clinical and histological clearance rates were 65.5% and 4.8% (P < .0001).

In the gel group, the clinical and histological clearance was independent of the lesion location, with the neck/trunk being 83.3% versus 72.2%, respectively, and the extremities being 83.1% versus 78.9%, respectively. The baseline size of main target lesions affected clearance rates, with clinical clearance of 90.7% at 81 mm² or less, 88.0% at 84 to 160 mm², and 73.1% at 165 mm² or more; histological clearance was 86.0%, 74.0%, and 69.2% at the same values.

After the completion of the first PDT cycle, 57.2% of patients with main target lesions treated with the gel showed complete clinical clearance compared with 14.3% who were given the vehicle (P < .0001).

Esthetic outcomes showed that 89.3% of lesions treated with the gel were good or very good compared with 58.0% in the vehicle group. Patients rated their satisfaction with the esthetic outcomes as very good or good, with 88.1% versus 74.0% for the gel and the vehicle, and 95.0% versus 100%, respectively, would choose the treatment again.

The most common treatment-emergent adverse effects included application site pain (95.2% vs 28.6%), application site erythema (69.0% vs 35.7%), application site pruritus (50.3% vs 26.2%), application site edema (29.0% vs 11.9%), and application site paresthesia (24.1% vs 11.9%).

Basal cell carcinoma is the most common cancer worldwide.