RP1 (vusolimogene oderparepvec) + nivolumab
FDA PDUFA Target Action Date · Replimune Group, Inc.
Note: Accelerated approval as TUDRIQEV (vusolimogene oderparepvec-wtpg) in combination with nivolumab for unresectable advanced cutaneous melanoma after progression on an anti-PD-1 regimen; announced 2026-08-06. CBER product, not yet in drugs.json. Source: https://www.globenewswire.com/news-release/2026/08/06/3340656/0/en/replimune-announces-fda-accelerated-approval-of-tudriqevtm-in-combination-with-nivolumab-for-unresectable-advanced-cutaneous-melanoma-after-progression-on-an-anti-pd-1-based-regime.html
Drug Information
- Application Type
- BLA (Class 1 resubmission)
- FDA Designations
- BreakthroughPriority Review
- Indication
- Advanced melanoma (progressed on anti-PD-1 containing regimen)
- Approved As
- RP1 (vusolimogene oderparepvec) + nivolumab
Filing Details
- Company
- Replimune Group, Inc. →
- Stock Ticker
- REPL
- SEC CIK
- 0001737953
- Source
- SEC 8-K →
What is a PDUFA Date?
A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.
- Standard Review: 10 months from filing acceptance
- Priority Review: 6 months from filing acceptance
- Possible Outcomes: Approval, Complete Response Letter (CRL), or extension
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Data sourced from SEC EDGAR filings. Last updated: 2026-06-29. Report an issue