{"entity":{"id":"vusolimogene-oderparepvec","kind":"drug","name":"Vusolimogene oderparepvec","aka":[],"tldr":"Vusolimogene oderparepvec is an engineered herpes virus injected into melanoma tumours, approved in August 2026 with nivolumab after immunotherapy failure.","summary":"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.","status":"approved","asOf":"2026-09-04","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Vusolimogene%20oderparepvec"}],"tags":[],"related":[],"cancers":["melanoma","advanced-melanoma"],"sections":[],"technologies":["oncolytic-virus"],"targets":[],"drugs":["nivolumab"],"companies":["replimune","bms"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06264180","nct06898970"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Tudriqev","code":"RP1","modality":"Oncolytic virus (HSV-1)","mechanism":"Selective replication in tumour cells, cell fusion and lysis, GM-CSF-driven antigen presentation.","approvals":[{"region":"US","year":2026,"indication":"Unresectable/metastatic melanoma after anti-PD-1, with nivolumab (accelerated)"}],"mechanismSteps":["Engineered HSV-1 is injected into a tumour","Virus replicates selectively in tumour cells (defective antiviral responses)","Cells lyse and fuse (GALV-GP R- fusogen), releasing antigens","Encoded GM-CSF recruits dendritic cells; interferon response follows","Nivolumab sustains the systemic T-cell response against uninjected lesions"],"dosing":{"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":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},"toxicity":[{"event":"Fatigue"},{"event":"Chills"},{"event":"Pyrexia"},{"event":"Nausea"},{"event":"Influenza-like illness"},{"event":"Injection-site pain"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2023-11","type":"designation","region":"US","note":"Breakthrough Therapy designation, anti-PD-1-failed melanoma","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2025-07-22","type":"crl","region":"US","note":"Complete response letter citing trial design and heterogeneity","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2026-08-06","type":"accelerated-approval","region":"US","note":"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":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"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"}]},"route":"/drugs/vusolimogene-oderparepvec/","neighbours":{"cancer":[{"id":"advanced-cutaneous-scc","kind":"cancer","name":"Advanced cutaneous squamous cell carcinoma","route":"/cancers/advanced-cutaneous-scc/"},{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"cutaneous-scc","kind":"cancer","name":"Cutaneous squamous cell carcinoma","route":"/cancers/cutaneous-scc/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"}],"technology":[{"id":"oncolytic-virus","kind":"technology","name":"Oncolytic viruses","route":"/technologies/oncolytic-virus/"}],"drug":[{"id":"nivolumab","kind":"drug","name":"Nivolumab","route":"/drugs/nivolumab/"}],"company":[{"id":"bms","kind":"company","name":"Bristol Myers Squibb","route":"/companies/bms/"},{"id":"replimune","kind":"company","name":"Replimune","route":"/companies/replimune/"}],"trial":[{"id":"nct06898970","kind":"trial","name":"Intratumoral Vusolimogene Oderparepvec (VO) in Combination With Pembrolizumab for Angiosarcoma","route":"/trials/nct06898970/"},{"id":"nct06264180","kind":"trial","name":"VO and Nivolumab vs Physician's Choice in Advanced Melanoma That Progressed on Anti-PD-1 & Anti-CTLA-4 Drugs [IGNYTE-3]","route":"/trials/nct06264180/"}],"pairing":[{"id":"oncolytic-plus-pd1","kind":"pairing","name":"Oncolytic virus + PD-1 blockade","route":"/pairings/oncolytic-plus-pd1/"}],"roadmap":[{"id":"immunotherapy-roadmap","kind":"roadmap","name":"Immunotherapy roadmap: Coley's toxins → checkpoint inhibitors → engineered immunity","route":"/roadmaps/immunotherapy-roadmap/"}],"person":[{"id":"kevin-harrington","kind":"person","name":"Kevin Harrington","route":"/people/kevin-harrington/"}],"bottleneck":[{"id":"b-tme-immunosuppression","kind":"bottleneck","name":"Cold tumours and the immunosuppressive microenvironment","route":"/bottlenecks/b-tme-immunosuppression/"}],"idea":[{"id":"idea-bio2-oncolytic-regulated-il12","kind":"idea","name":"Oncolytic viruses that make interleukin-12 only inside the tumour","route":"/ideas/idea-bio2-oncolytic-regulated-il12/"}],"paper":[{"id":"paper-wong-ignyte-rp1-nivolumab-jco-2025","kind":"paper","name":"IGNYTE: an engineered herpes virus with nivolumab in melanoma that had already failed anti-PD-1 therapy","route":"/key-papers/paper-wong-ignyte-rp1-nivolumab-jco-2025/"}],"pathway":[{"id":"immune-desert-exclusion","kind":"pathway","name":"Cold tumours: immune deserts and exclusion","route":"/pathways/immune-desert-exclusion/"}]}}