FDA advisory panel backs experimental Replimune melanoma therapy after two prior rejections

An FDA advisory committee voted 10‑to‑3 to recommend the use of an experimental Replimune treatment for patients with advanced melanoma.

The panel’s recommendation marks a shift after the agency previously rejected the therapy twice, suggesting new data may have swayed the experts.

If the FDA follows the advisory panel’s advice, the treatment could move closer to approval, offering a potential new option for a disease with limited effective therapies.