Replimune Group announced that the FDA has issued a Complete Response Letter (CRL) for the company’s Biologics License Application (BLA) seeking approval of RP1 in combination with nivolumab for the treatment of advanced melanoma.
According to Replimune, the FDA determined that the submitted data were not sufficient to support approval of the application at this time. The company stated that the application was supported by results from the Phase 2 IGNYTE trial, which evaluated RP1 plus nivolumab in patients who had disease progression on prior anti–PD-1 therapy. In that study, Replimune reported a 34% response rate and a median response duration of 24.8 months.
Replimune indicated that the FDA’s decision followed changes in the review team assigned to the resubmission. The company said the new review group did not meet with Replimune during the review process. It also noted that the agency’s feedback in the CRL differed from positions discussed in prior regulatory meetings, including those in 2021 and 2025.
RP1 previously received breakthrough therapy designation and priority review from the FDA. The company said it has initiated the global Phase 3 IGNYTE-3 trial as a confirmatory study required for potential accelerated approval.
Replimune stated that, following the CRL, it plans to reduce its workforce and scale back U.S.-based manufacturing operations. The company did not indicate whether it intends to resubmit the BLA.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!