06/02/2026
– Following the U.S. Food and Drug Administration’s second decision to deny approval of RP1 (vusolimogene oderparepvec) in combination with nivolumab (Opdivo), we are encouraged that the study sponsor will resubmit its Biologics License Application (BLA) for approval reconsideration. RP1 is a pioneering treatment with promise for patients with anti-PD1 refractory metastatic melanoma who did not find success with other FDA approved therapeutics or clinical trials. The FDA has indicated it will prioritize its review to address the significant unmet need for the advanced melanoma patient community.
Referring to the RP1 BLA resubmission, Yana Najjar, MD, Associate Professor of Medicine and Director of the Clinical and Translational Research Center UPMC Hillman Cancer Center shared, “The melanoma medical oncology community has firmly stood behind Replimune’s data from the time of initial submission to the FDA. We, like the melanoma patient and advocacy communities, were very disappointed by the agency’s decision not to approve a drug that has demonstrated safety and efficacy in a very difficult to treat population. I am hopeful that the FDA’s decision to re-review the RP1 BLA means that we are one step closer to being able to bring this drug to patients. Approval would mean that patients who currently don’t have treatment options available to them after progressing on immunotherapy would now have access to a drug that significantly- and durably- reduces tumor burden in at least 30% of patients, without major toxicity. Over 8000 patients die of metastatic melanoma in the United States each year. With the recent 3-year survival data that was shown at ASCO this weekend, approval would mean that we are able to do what we first and foremost need to do: decrease the number of patients who succumb to this disease annually."
Of note, enrollments into the REVEAL trial which evaluates RP2 + nivolumab in metastatic uveal melanoma patients will continue. To learn more about this study, visit - https://www.replimune.com/clinical-trials
Thank you to the healthcare provider community and the countless patients who have continued to advocate for this monumental treatment approval.
To learn more, visit - https://ir.replimune.com/news-releases/news-release-details/replimune-announces-planned-rp1-bla-resubmission-following
