The US Food and Drug Administration (FDA) has accepted the resubmission of Replimune Group, Inc.’s Biologics License Application (BLA) for RP1 in combination with nivolumab (Opdivo, Bristol Myers Squibb) for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen.
The PDUFA date set by the FDA is April 10, 2026, based on a Class II resubmission timeline.
“We are pleased the agency has accepted the resubmission of our BLA for RP1,” says Sushil Patel, PhD, CEO of Replimune, in a news release. “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. We look forward to working closely with the agency to expedite this review as much as possible for patients’ benefit.”
During the past few months, Replimune has been working to address agency feedback. Additional information, data, and analyses were included in the resubmission, which will be part of the BLA review.
The FDA indicated this resubmission is considered to be a complete response to the complete response letter received in July 2025.
This summer, the FDA rejected Replimune’s request for approval of RP1 stating that the trial data wasn’t able to be “adequately interpreted due to the heterogeneity of the patient population,” according to a news release from the Company.
