{"entity":{"id":"talimogene-laherparepvec","kind":"drug","name":"Talimogene laherparepvec","aka":[],"tldr":"Talimogene laherparepvec (T-VEC, Imlygic) was the first approved oncolytic virus (2015), injected into melanoma skin lesions.","summary":"Talimogene laherparepvec (T-VEC) is a herpes simplex virus type 1 with ICP34.5 and ICP47 deleted, so it replicates in tumour cells but not healthy ones, and it expresses GM-CSF to attract antigen-presenting cells. It was the first approved oncolytic virus (2015), injected into unresectable melanoma lesions at 10^6 PFU/mL initially, then 10^8 PFU/mL 3 weeks later and every 2 weeks. In OPTiM the durable response rate was 16% versus 2% for GM-CSF alone. Uptake has been modest because responses concentrate in injected lesions, and the MASTERKEY-265 combination with pembrolizumab did not improve progression-free or overall survival. Amgen markets it; its legacy is proving the principle that later viruses build on. For a newcomer: the first cancer-killing virus approved, useful mainly for accessible skin lesions.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Talimogene_laherparepvec","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Talimogene%20laherparepvec"}],"tags":[],"related":[],"cancers":["melanoma","advanced-melanoma","stage-iii-melanoma"],"sections":[],"technologies":["oncolytic-virus"],"targets":[],"drugs":[],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":["nct02263508","nct00769704","nct01368276"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Imlygic","code":"T-VEC","modality":"Oncolytic virus (HSV-1)","mechanism":"HSV-1 with ICP34.5 and ICP47 deleted, expressing GM-CSF.","approvals":[{"region":"US","year":2015,"indication":"Unresectable melanoma with injectable lesions"}],"mechanismSteps":["HSV-1 with ICP34.5 and ICP47 deleted is injected into melanoma lesions","Replicates in tumour cells and lyses them","GM-CSF expression attracts antigen-presenting cells","Local and some distant lesions regress"],"dosing":{"route":"Intratumoural injection","schedule":"10⁶ PFU/mL initial dose, then 10⁸ PFU/mL 3 weeks later and every 2 weeks; volume by lesion size (up to 4 mL total)","monitoring":"Herpetic infection, injection-site complications, immune-mediated events","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"},{"country":"UK","reimbursement":"NICE: recommended for unresectable melanoma when systemic immunotherapy is unsuitable (TA410)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2015-10-27","type":"approval","region":"US","note":"Unresectable melanoma with injectable lesions (OPTiM): first oncolytic virus approved in the US","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2015-12","type":"approval","region":"EU","note":"EMA approval","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/talimogene-laherparepvec/","neighbours":{"cancer":[{"id":"advanced-melanoma","kind":"cancer","name":"Advanced melanoma (unresectable stage III and stage IV)","route":"/cancers/advanced-melanoma/"},{"id":"melanoma","kind":"cancer","name":"Melanoma","route":"/cancers/melanoma/"},{"id":"merkel-cell-carcinoma","kind":"cancer","name":"Merkel cell carcinoma","route":"/cancers/merkel-cell-carcinoma/"},{"id":"stage-iii-melanoma","kind":"cancer","name":"Stage III melanoma (after surgery)","route":"/cancers/stage-iii-melanoma/"}],"technology":[{"id":"isolated-limb-perfusion","kind":"technology","name":"Isolated limb perfusion and infusion","route":"/technologies/isolated-limb-perfusion/"},{"id":"oncolytic-virus","kind":"technology","name":"Oncolytic viruses","route":"/technologies/oncolytic-virus/"}],"company":[{"id":"amgen","kind":"company","name":"Amgen","route":"/companies/amgen/"},{"id":"omega-funds","kind":"company","name":"Omega Funds","route":"/companies/omega-funds/"}],"trial":[{"id":"nct01368276","kind":"trial","name":"An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma","route":"/trials/nct01368276/"},{"id":"nct00769704","kind":"trial","name":"Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma","route":"/trials/nct00769704/"},{"id":"nct02263508","kind":"trial","name":"Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma","route":"/trials/nct02263508/"}],"target":[{"id":"csf2ra","kind":"target","name":"GM-CSF receptor (CSF2RA)","route":"/targets/csf2ra/"}],"pairing":[{"id":"oncolytic-plus-pd1","kind":"pairing","name":"Oncolytic virus + PD-1 blockade","route":"/pairings/oncolytic-plus-pd1/"}],"person":[{"id":"howard-kaufman","kind":"person","name":"Howard L. Kaufman","route":"/people/howard-kaufman/"},{"id":"igor-puzanov","kind":"person","name":"Igor Puzanov","route":"/people/igor-puzanov/"},{"id":"kevin-harrington","kind":"person","name":"Kevin Harrington","route":"/people/kevin-harrington/"},{"id":"reinhard-dummer","kind":"person","name":"Reinhard Dummer","route":"/people/reinhard-dummer/"}],"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-andtbacka-optim-talimogene-jco-2015","kind":"paper","name":"OPTiM: the trial that made talimogene laherparepvec the first approved oncolytic virus","route":"/key-papers/paper-andtbacka-optim-talimogene-jco-2015/"},{"id":"paper-shalhout-oncolytic-progress-challenges-natrevclinonc-2023","kind":"paper","name":"Shalhout 2023: what the approved oncolytic viruses actually do in practice","route":"/key-papers/paper-shalhout-oncolytic-progress-challenges-natrevclinonc-2023/"}],"term":[{"id":"vaccines-and-oncolytic-viruses","kind":"term","name":"Cancer vaccines and oncolytic viruses","route":"/terms/vaccines-and-oncolytic-viruses/"}],"institution":[{"id":"usz-zurich","kind":"institution","name":"University Hospital Zurich / Comprehensive Cancer Center Zurich","route":"/institutions/usz-zurich/"}],"pathway":[{"id":"immune-desert-exclusion","kind":"pathway","name":"Cold tumours: immune deserts and exclusion","route":"/pathways/immune-desert-exclusion/"}],"drug":[{"id":"daromun","kind":"drug","name":"Daromun","route":"/drugs/daromun/"}]}}