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April 13, 2026

FDA issues complete response letter to Replimune’s RP1 for melanoma

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Replimune Group’s biologics licence application (BLA) concerning the RP1 therapy in combination with nivolumab for advanced melanoma.

During the IGNYTE trial, patients treated with RP1 plus nivolumab showed a 34% response rate. Credit: Evgeniy Kalinovskiy / Shutterstock.com.