Replimune's RP1 BLA Accepted with August 2 FDA Goal Date
REPL•Replimune’s BLA resubmission for RP1 plus nivolumab received FDA acceptance with an August 2, 2026 goal date. The FDA has scheduled an advisory committee meeting in late July to review RP1 for advanced melanoma patients who progressed on anti-PD-1 therapy.
1. FDA Acceptance of RP1 BLA
The FDA has accepted Replimune’s resubmitted BLA for RP1 in combination with nivolumab under a class 1 review, setting an action goal date of August 2, 2026. This marks a complete submission for advanced melanoma treatment following progression on anti-PD-1 therapy.
2. Advisory Committee Meeting Timing
The agency has notified Replimune of an advisory committee meeting in late July to evaluate the risk-benefit profile of RP1. Advisory panel feedback will inform the FDA's final decision on potential accelerated approval.
3. IGNYTE Trial Data and RP1 Profile
RP1 is an oncolytic herpes simplex virus engineered with a fusogenic protein and GM-CSF, tested in the IGNYTE trial alongside nivolumab. Data showed responses in patients who failed prior anti-PD-1 regimens, highlighting RP1's potential in a high-unmet-need population.
