FDA Approved New Skin Cancer Light Therapy
Adults with superficial basal cell carcinoma now have a non-invasive photodynamic therapy option.
Updated on Sept. 28, 2026 in Cancer
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The FDA has approved the use of Ameluz topical gel in combination with a specialized lamp to treat superficial basal cell carcinoma. This is the first photodynamic therapy drug cleared for skin cancer in the United States.
Why it matters
This approval provides a new, non-surgical treatment pathway for patients, potentially facilitating broader insurance coverage and offering a validated clinical alternative to standard procedures.
In a phase 3 trial of 95 participants, 66% achieved a complete response of the target lesion 12 weeks after treatment. All trial participants reported at least one adverse reaction at the application site.
The players
FDA
The United States federal agency responsible for protecting public health by regulating pharmaceuticals and medical devices.
The details
The treatment uses a 10% concentration of Ameluz gel, which is absorbed by cells over a 3-hour incubation period. Once applied, the agent converts into protoporphyrin IX, which reacts with red light from a BF-RhodoLED lamp to create reactive oxygen that destroys atypical cells. The FDA advises against using the gel near mucous membrane areas.
Timeline
1999: Ameluz was first approved for the treatment of actinic keratoses.
12 weeks after treatment: The primary endpoint assessment was conducted in the phase 3 trial.
Health Landscape
This approval marks a significant expansion for a drug previously cleared for actinic keratoses in 1999. It represents the first time photodynamic therapy has been formally authorized for the treatment of skin cancer in the United States.
Patients diagnosed with superficial basal cell carcinoma should discuss with their dermatologist whether photodynamic therapy is an appropriate clinical path for their specific case. Be aware that the treatment requires a 3-hour application window followed by light exposure, and site-specific reactions are common.
The takeaway
This new therapy offers a non-surgical option for superficial skin cancer treatment by using light-activated medication to destroy atypical cells. If you have been diagnosed with this condition, ask your doctor about the potential benefits and limitations of photodynamic therapy compared to standard care.
Further reading
Learn more about evolving options and clinical standards in our Cancer section.
Source note: This article includes information reported by Medscape.
Live Poll
Would you prefer a non-surgical photodynamic therapy over surgery for early-stage skin cancer?
