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Medical Daily
Medical Daily
Ryan Archer

FDA advisers backed Replimune's RP1 melanoma therapy, bringing the investigational skin cancer drug closer to approval for advanced melanoma.

A skin cancer treatment developed by Replimune Group has moved a step closer to potential approval after an advisory committee to the U.S. Food and Drug Administration (FDA) voted in favor of the company's experimental therapy, RP1 (vusolimogene oderparepvec). The recommendation has renewed attention on the investigational drug, which is designed to treat certain patients with advanced melanoma, the most serious form of skin cancer.

Although the FDA is not required to follow advisory committee recommendations, it often considers their advice when making final regulatory decisions. According to Reuters, the panel concluded that the available evidence supported a favorable benefit-risk profile for the therapy in its proposed patient population. The committee's recommendation is advisory and does not constitute final FDA approval.

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