Photodynamic Therapy for the Most Common Skin Cancer Wins Approval

The FDA approved aminolevulinic acid hydrochloride 10% (Ameluz) in combination with photodynamic therapy for treating adults with superficial basal cell carcinoma, maker Biofrontera announced on Monday.

The approval represents a non-surgical option for the most common type of skin cancer. The photosensitizing gel must be applied by a healthcare provider and is meant to be used with the company’s BF-RhodoLED lamp. The same topical gel/red-light device combination was previously approved for actinic keratoses of the face and scalp in adults.

Support for the new indication came from a vehicle-controlled phase III trial of 187 adults with histologically confirmed superficial basal cell carcinoma. Twelve weeks after the start of the last treatment cycle, significantly more patients achieved the composite outcome of clinical and histological complete response with photodynamic therapy plus aminolevulinic acid gel versus vehicle (66% vs 5%).

Both components of the primary endpoint also significantly favored the active treatment:

• Histological clearance: 76% vs 19%
• Clinical clearance: 83% vs 21%

More than 3.5 million cases of basal cell carcinoma are diagnosed each year in the U.S., and an estimated 15% to 20% of those are cases of superficial basal cell carcinoma, which often present as multiple lesions on the trunk and extremities. Surgery is the standard approach but not always ideal.

“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 investigator M. Shane Chapman, MD, MBA, of Dartmouth Geisel School of Medicine in Hanover, New Hampshire.

“This FDA approval for Ameluz and the RhodoLED gives us a rigorously studied, non-surgical option that we can deliver in our office,” added Chapman. “As someone who has worked with [photodynamic therapy] for many years, I see this as a meaningful expansion in the use of this treatment.”

Photodynamic therapy, with photosensitizers such as 5-aminolevulinic acid or methyl aminolevulinate, is already recommended in guidelines for low-risk skin cancers such as superficial basal cell carcinomas.

According to the prescribing information for photodynamic therapy with aminolevulinic acid, common adverse events include application site erythema, pain or burning, irritation, edema, pruritus, exfoliation, scabs, induration, vesicles, and paresthesia.

Warnings and precautions include risks for hypersensitivity reactions, transient amnestic episodes, eye injury from the red-light therapy (protective eyewear should be used for patient and clinician alike), ophthalmic adverse events if aminolevulinic acid comes into contact with the eyes, increased photosensitivity, and mucous membrane irritation.