Home / Health / FDA Accepts Replimune's Resubmission for Melanoma Treatment RP1
FDA Accepts Replimune's Resubmission for Melanoma Treatment RP1
20 Oct
Summary
- FDA accepts Replimune's resubmission of BLA for RP1 treatment
- RP1 combined with nivolumab targets advanced melanoma patients
- PDUFA date set for April 10, 2026 after Class II resubmission
On October 20, 2025, the U.S. Food and Drug Administration (FDA) accepted Replimune Group Inc's resubmission of a Biologics License Application (BLA) for its RP1 treatment. The BLA seeks approval for RP1 in combination with nivolumab to treat advanced melanoma patients who have progressed on anti-PD-1 containing regimens.
This acceptance represents a significant milestone for Replimune, following the complete response letter it received from the FDA in July 2025. The company has been working to address the agency's feedback over the past few months, including providing additional information, data, and analyses in its resubmission.
The FDA has set a Prescription Drug User Fee Act (PDUFA) date of April 10, 2026, based on a Class II resubmission timeline. "We are pleased the agency has accepted the resubmission of our BLA for RP1," said Sushil Patel, Ph.D., CEO of Replimune. "RP1 plus nivolumab offers a strong risk benefit profile where there are few options for patients with advanced melanoma, who have progressed on PD-1 based therapy."
