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drugsProductApproved2015🇪🇺🇬🇧🇦🇺

Talimogene laherparepvec

Talimogene laherparepvec (T-VEC, Imlygic) was the first approved oncolytic virus (2015), injected into melanoma skin lesions.

OPTiM: durable response rate 16% vs 2% for GM-CSF. Modest uptake; combination with pembrolizumab (MASTERKEY-265) did not improve PFS/OS. Amgen.

Schematic of the modality · Oncolytic virus (HSV-1) · not a molecule; see the Oncolytic viruses page
Mechanism, step by step
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1.HSV-1 with ICP34.5 and ICP47 deleted is injected into melanoma lesions

Modality
Oncolytic virus (HSV-1)
Mechanism
HSV-1 with ICP34.5 and ICP47 deleted, expressing GM-CSF.
Brand / code
Imlygic · T-VEC
Dosing & schedule
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: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.

Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Intralesional injection by the clinician; HCPCS J9325.

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

NICE recommendedNICE TA410 · 2016SMC: accepted (restricted)
Appraised for
Unresectable regionally or distantly metastatic melanoma (stage IIIB-IVM1a) when systemically administered immunotherapy is not suitable
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA410 · SMC advice: talimogene laherparepvec. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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  1. 27 Oct 2015ApprovalUS

    Unresectable melanoma with injectable lesions (OPTiM): first oncolytic virus approved in the US source

  2. Dec 2015ApprovalEU

    EMA approval source

Approvals

RegionYearIndication
US2015Unresectable melanoma with injectable lesions

Safety

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Toxicity profile
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.

Cost & access

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Cost & access
CountryReimbursement
United StatesMedicare Part B (physician-administered); commercial plans per formulary
United KingdomNICE: recommended for unresectable melanoma when systemic immunotherapy is unsuitable (TA410)

List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
33 studies2 recruiting28 Phase 25 Phase 3
Search “Talimogene laherparepvec” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Talimogene laherparepvec
intervention: Talimogene laherparepvec
Open on ClinicalTrials.gov →

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Latest papers

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Literature trend49 papers in the last 12 months+11% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Talimogene laherparepvec" OR ABSTRACT:"Talimogene laherparepvec" OR TITLE:"Imlygic" OR ABSTRACT:"Imlygic" OR TITLE:"T-VEC" OR ABSTRACT:"T-VEC") 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 Talimogene laherparepvec, not a curated reading list.

Connected

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