Objective:

To report the FDA approval of aminolevulinic acid hydrochloride (Ameluz) for the treatment of superficial basal cell carcinoma (BCC) in combination with photodynamic therapy.

Approach:

• FDA Approval: The FDA approved Ameluz topical gel, 10%, for adults with superficial BCC, expanding its indication from actinic keratosis.
• Clinical Trial: A phase 3 trial with 187 adults assessed the efficacy of Ameluz in achieving clinical and histological complete response.

Key Findings:

• 95 of 145 patients (66%) treated with Ameluz achieved the primary end point compared to 2 of 42 patients (5%) receiving placebo photodynamic therapy.
• Histological clearance of the main target lesion occurred in 76% of patients treated with Ameluz compared with 19% receiving placebo photodynamic therapy.
• Complete clinical clearance of all target lesions occurred in 83% of patients receiving Ameluz compared with 21% receiving placebo photodynamic therapy.

Interpretation:

Application-site reactions were the most frequently observed adverse reactions.

Limitations:

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Conclusion:

Ameluz represents a new treatment option for patients with superficial BCC.

Sources:

• Biofrontera Press Release