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Vusolimogene oderparepvec is an engineered herpes virus injected into melanoma tumours, approved in August 2026 with nivolumab after immunotherapy failure.
Vusolimogene oderparepvec (RP1) is an engineered herpes simplex virus type 1 that replicates selectively in tumour cells, expresses GM-CSF to recruit antigen-presenting cells and carries the GALV-GP R- fusogenic protein. It is injected into melanoma lesions at 1 x 10^6 PFU/mL for the first dose, then 1 x 10^7 PFU/mL every 2 weeks for up to 8 cycles, with nivolumab. In IGNYTE the combination produced a response rate of about 33% in melanoma that had failed anti-PD-1 therapy, including shrinkage of uninjected lesions, evidence of a systemic immune effect. The FDA issued a complete response letter in July 2025 and then granted accelerated approval on 6 August 2026; the randomised IGNYTE-3 trial must confirm the benefit. Replimune developed it. For a newcomer: a tumour-injected virus that helps immunotherapy work again in melanoma.
Selective replication in tumour cells, cell fusion and lysis, GM-CSF-driven antigen presentation.
1.Engineered HSV-1 is injected into a tumour
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
Sources: NICE search: vusolimogene oderparepvec. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Breakthrough Therapy designation, anti-PD-1-failed melanoma source
Complete response letter citing trial design and heterogeneity source
In combination with nivolumab for treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen
Accelerated approval with nivolumab for unresectable/metastatic melanoma after anti-PD-1 (IGNYTE) The confirmatory requirement was still open 0.1 years later, when the FDA's table was read. source
| 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.
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Query 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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