FDA Clears First Skin-Cancer Photodynamic Therapy

FDA has approved Biofrontera’s Ameluz-PDT to treat superficial basal cell carcinoma, making it the first photodynamic therapy drug cleared in the United States for an actual skin cancer rather than a pre-cancerous lesion. The approval, announced 14 September 2026, rests on a Phase 3 trial in which two out of three treated patients cleared their target lesion — and it lands more than two weeks ahead of the FDA’s own target action date.

From a precancerous label to an oncology one

Ameluz has been on the U.S. market for a decade under a narrower label. FDA first approved it on 10 May 2016 for lesion-directed and field-directed treatment of mild-to-moderate actinic keratosis on the face and scalp — sun-damaged patches of skin that can, left untreated, progress toward cancer, but that are not cancer themselves. The 14 September approval is the first time FDA has let the same drug-device combination be marketed to treat a skin cancer outright: superficial basal cell carcinoma, the most common form of the most common human cancer.

The mechanism does not change between the two indications. Ameluz is a prodrug: applied topically, it is converted inside abnormal cells into a photosensitizing compound, protoporphyrin IX, which accumulates preferentially in the target tissue. Illuminating the treated area with red light from the BF-RhodoLED lamp then triggers a photochemical reaction that destroys those cells while sparing surrounding healthy skin — the same principle Biofrontera has marketed for actinic keratosis since 2016, now supported by its own dedicated trial in an oncologic indication.

What the pivotal trial found

The approval rests on a multicenter, randomized, double-blind, vehicle-controlled Phase 3 study enrolling 187 adults with histologically confirmed superficial basal cell carcinoma. The trial’s primary endpoint was a composite of clinical and histological complete response in a main target lesion, assessed 12 weeks after the final PDT cycle. Sixty-six percent of patients treated with Ameluz-PDT met that bar, against 5% of patients who received placebo-PDT — the light exposure and treatment ritual without the active drug.

• Design: randomized, double-blind, vehicle-controlled Phase 3 trial, 187 adults with histologically confirmed superficial BCC.
• Primary endpoint: composite clinical and histological complete response of a main target lesion, 12 weeks after the final PDT cycle.
• Result: 66% complete response with Ameluz-PDT versus 5% with placebo-PDT.
• Regulatory path: supplemental NDA, filed 2 December 2025, accepted 11 February 2026, approved 14 September 2026 — ahead of the 28 September target action date.

A non-surgical option for a very common tumor

Basal cell carcinoma is the most commonly diagnosed cancer in the United States, and superficial BCC — a thin, slow-growing subtype confined to the outer skin layer — is typically managed today with surgical excision, curettage and electrodesiccation, or topical chemotherapy agents such as imiquimod and 5-fluorouracil. A cleared photodynamic option gives dermatologists an additional non-surgical route for a tumor type where cosmetic outcome and avoiding a scar are often a real consideration for patients, particularly for lesions on visible areas.

“FDA approval of Ameluz for superficial basal cell carcinoma is a defining milestone for Biofrontera,” said Hermann Luebbert, CEO and Chairman of Biofrontera. “Ameluz is now the first and only photodynamic therapy approved in the United States to treat a skin cancer, which sets our platform apart in medical dermatology and gives dermatologists an effective, non-surgical option for a very common tumor.”

What comes next for the label

The sBCC approval does not stand alone in Biofrontera’s pipeline. The company has said it plans to submit a separate supplemental application in the third quarter of 2026 seeking to expand Ameluz’s existing actinic keratosis indication beyond the face and scalp to the extremities, neck and trunk — a Phase 3 trial for that expansion has already completed enrollment. Between the two filings, Biofrontera is working to widen both where Ameluz can be used on the body and what it can be used to treat, on the strength of a drug-device combination whose underlying mechanism has not changed since 2016.

Frequently asked questions

What did FDA approve on 14 September 2026?

A supplemental New Drug Application for Biofrontera's Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, used with red-light photodynamic therapy from the BF-RhodoLED lamp series, to treat superficial basal cell carcinoma in adults. It is the first photodynamic therapy FDA has approved to treat a skin cancer; Ameluz was previously approved only for actinic keratosis, a pre-cancerous condition.

What did the trial show?

A multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial in 187 adults with histologically confirmed superficial basal cell carcinoma. The primary endpoint — a composite of clinical and histological complete response of a main target lesion 12 weeks after the last PDT cycle — was met by 66% of patients treated with Ameluz-PDT, versus 5% of patients treated with placebo-PDT.

How is this different from Ameluz's original approval?

Ameluz was first approved on 10 May 2016 for lesion- and field-directed treatment of mild-to-moderate actinic keratosis on the face and scalp — a pre-cancerous skin condition, not a cancer. The new approval extends the same drug-device combination to an actual malignancy, superficial basal cell carcinoma, treated non-surgically.

When was the application filed and accepted?

Biofrontera announced it had filed the supplemental application on 2 December 2025. FDA accepted it for review on 11 February 2026, with a target action date of 28 September 2026. The agency approved it on 14 September 2026, more than two weeks ahead of that date.