REPL AdComm: Jul 30, 2026
Replimune Group · Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC).
✓ Panel voted 10-3 favorable
On Jul 30, 2026 the CTGTAC voted 10 for, 3 against that the efficacy results from the IGNYTE study are evaluable and clinically meaningful for RP1 (vusolimogene oderparepvec) in combination with nivolumab in advanced melanoma previously treated with an anti-PD-1 regimen. The vote is non-binding; the FDA's action goal date is Aug 2, 2026.
Meeting dateJul 30, 2026
CommitteeCTGTAC
CompanyReplimune Group
DrugVusolimogene oderparepvec (RP1) + nivolumab
IndicationAdvanced melanoma
Panel vote10 for · 3 against: FAVORABLE (evaluable & clinically meaningful)
ApplicationBLA 125827
Result sourceReplimune press release (Jul 30 2026) →
Meeting noticeFDA Federal Register notice →
An advisory committee vote is a public panel review; it is advisory only; the FDA makes the final decision at the PDUFA date. All AdComm meetings →
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Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
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