Also known as: RP1
RP1 (vusolimogene oderparepvec) is Replimune's lead oncolytic immunotherapy candidate, engineered from HSV-1 and armed with GALV-GP R- and GM-CSF to drive local tumor lysis and systemic anti-tumor immunity. It has been evaluated in combination with nivolumab for advanced melanoma and remains an investigational therapy. In July 2025, FDA issued a complete response letter for its BLA in advanced melanoma.
Replimune said the FDA issued a complete response letter for its RP1 plus nivolumab application in advanced melanoma. The company disputed the agency’s assessment and said it will cut jobs and scale back U.S. manufacturing.
The FDA accepted Replimune’s BLA resubmission for RP1 plus nivolumab in advanced melanoma. The agency set an April 10, 2026 PDUFA date under a Class II resubmission timeline.
Replimune Group Inc. approaches a critical regulatory milestone as the FDA is scheduled to decide on its RP1 melanoma therapy by April 10, 2026, with cash reserves extending into early 2027.
