Kevin Harrington, Professor in Biological Cancer Therapies at Institute of Cancer Research, shared a post on LinkedIn:
“It was really heartening to learn earlier this week that the FDA has accepted Replimune’s resubmission for a Biologics License Agreement (BLA) for RP1 (Vusolimogene oderparepvec). The original submission, which was based on highly promising IGNYTE phase II data in 140 patients with immunotherapy-refractory melanoma, was rejected in July 2025.
This led to a significant outpouring of opinion in support of RP1 as a clinically important therapy from clinicians, fundamental and translational research leaders, melanoma/skin cancer charities and, most importantly, patients and patient interest groups. At the same time, in response to the initial decision, Replimune appears to have worked very hard in addressing the agency’s concerns and there is now every reason to hope that the Prescription Drug User Fee Act (PDUFA) meeting scheduled for 10th April 2026 will lead to a successful outcome.
I congratulate both Replimune and the FDA for the position that they have reached.
In particular, the FDA has demonstrated that it is capable of listening to dissenting voices and is responsive to the views of the scientific and medical communities. The Agency has clearly demonstrated that it is committed to helping to bring important new therapies to patients.”
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FDA Accepts Resubmission for RP1 Oncolytic Immunotherapy Plus Nivolumab in PD-1–Refractory Melanoma
