Vusolimogene oderparepvec
Vusolimogene oderparepvec is an engineered herpes virus injected into melanoma tumours, approved in August 2026 with nivolumab after immunotherapy failure.
Replimune's RP1 expresses GM-CSF and GALV-GP R- fusogenic protein. IGNYTE: ORR ~33% in anti-PD-1-failed melanoma, including uninjected lesions. FDA issued a complete response letter in July 2025 then granted accelerated approval on 6 August 2026 with nivolumab. Confirmatory IGNYTE-3 ongoing.
1.Engineered HSV-1 is injected into a tumour
- Route
- Intratumoural injection
- Schedule
- 1 × 10⁶ PFU/mL first dose, then 1 × 10⁷ PFU/mL every 2 weeks for up to 8 cycles (injectable lesions up to 10 mL), with nivolumab
- Monitoring
- Injection-site reactions, flu-like symptoms, herpetic infection precautions
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: vusolimogene oderparepvec. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- Nov 2023DesignationUS
Breakthrough Therapy designation, anti-PD-1-failed melanoma source
- 22 Jul 2025Complete response letterUS
Complete response letter citing trial design and heterogeneity source
- 6 Aug 2026ApprovalUS
Accelerated approval with nivolumab for unresectable/metastatic melanoma after anti-PD-1 (IGNYTE) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2026 | Unresectable/metastatic melanoma after anti-PD-1, with nivolumab (accelerated) |
| Adverse event |
|---|
| Fatigue |
| Chills |
| Pyrexia |
| Nausea |
| Influenza-like illness |
| Injection-site pain |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Vusolimogene oderparepvec" OR ABSTRACT:"Vusolimogene oderparepvec" OR TITLE:"Tudriqev" OR ABSTRACT:"Tudriqev") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Vusolimogene oderparepvec, not a curated reading list.
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