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.
1.HSV-1 with ICP34.5 and ICP47 deleted is injected into melanoma lesions
- 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.
- Assistance programmes
- Amgen SupportPlus
- Amgen Safety Net Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- 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.
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- 27 Oct 2015ApprovalUS
Unresectable melanoma with injectable lesions (OPTiM): first oncolytic virus approved in the US source
- Dec 2015ApprovalEU
EMA approval source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2015 | Unresectable melanoma with injectable lesions |
| 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 | — |
| United Kingdom | NICE: recommended for unresectable melanoma when systemic immunotherapy is unsuitable (TA410) | 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:"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.
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