FDA issues complete response letter to Replimune’s RP1 for melanoma
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The US FDA has issued a complete response letter to Replimune's biologics license application for RP1, a therapy for advanced melanoma. The decision affects Replimune's lead product candidate, which has shown a 34% response rate and a median duration of 24.8 months in clinical trials.
The US FDA has issued a complete response letter to Replimune's biologics license application for RP1. RP1 is a genetically engineered herpes simplex virus intended to stimulate an anti-tumour immune response. In clinical trials, patients treated with RP1 plus nivolumab showed a 34% response rate and a median duration of 24.8 months. The FDA's decision deviated from previous discussions, prompting Replimune to reconsider its development plans. Replimune contends the results warrant making the therapy accessible to cancer patients. The company will substantially scale back its US-based manufacturing operations.
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