Imlygic (talimogene laherparepvec) · Amgen
IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases.
Details
- Status
- Prescription
- First Approved
- 2015-10-26
- Patent Cliff
- 2022
- Routes
- Intralesional
- Dosage Forms
- For Injection
Imlygic Approval History
What Imlygic Treats
1 FDA approvalsOriginally approved for its first indication in 2015 .
- Other (1)
Other
(1 approval)- • Approved indication (Oct 2015)
Imlygic Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Amgen's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
32 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02923778 | NCI-2016-01461 NCI-2016-01461, MC1678 | Ph 2 | active not recruiting | Talimogene Laherparepvec and Radiation Therapy in Treating Patients With Newly Diagnosed Soft Tissue Sarcoma That Can Be Removed by Surgery |
| NCT02978625 | NCI-2016-01804 NCI-2016-01804, CINJ #091701 | Ph 2 | active not recruiting | Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers |
| NCT07102394 | IRB00482551 | Ph 1 | recruiting | Feasibility and Tolerability of IMLYGIC for the Treatment of Cutaneous Neurofibromas in Adults With NF1 |
| NCT02779855 results posted | MCC-18621 | Ph 1, Ph 2 | completed | Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer |
| NCT04599062 results posted | 201504731 (8 milliliter dose) | Ph 1, Ph 2 | active not recruiting | TVEC and Preop Radiation for Sarcoma (8 ml Dose) |
| NCT04163952 results posted | Pro2018002628 NCI-2019-06083, Pro2018002628 | Ph 1 | terminated | Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin |
| NCT06660810 | 202402722 | Ph 2 | active not recruiting | Neoadjuvant Intralesional Injection of Talimogene Laherparepvec |
| NCT02965716 results posted | NCI-2016-01698 NCI-2016-01698, S1607 | Ph 2 | active not recruiting | Talimogene Laherparepvec and Pembrolizumab in Treating Patients With Stage III-IV Melanoma |
| NCT03554044 | 17753 NCI-2018-00652 | Ph 1 | completed | T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer |
| NCT04068181 results posted | 20180115 2019-001906-61 | Ph 2 | completed | Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07). |
| NCT03086642 | AAAQ9966 1R01FD006108-01 | Ph 1 | completed | Study of Talimogene Laherparepvec (T-VEC) in Pancreatic Cancer |
| NCT03663712 TEMPO results posted | Pro00086917 | Ph 1 | completed | Talimogene Laherparepvec for the Treatment of Peritoneal Surface Malignancies |
| NCT02509507 MASTERKEY-318 results posted | 20140318 2014-005386-67 | Ph 1, Ph 2 | completed | Trial to Evaluate the Safety of Talimogene Laherparepvec Injected Into Tumors Alone and in Combination With Systemic Pembrolizumab MK-3475-611/Keynote-611 |
| NCT02453191 results posted | 201504731 (4 milliliter dose) | Ph 1, Ph 2 | completed | TVEC and Preop Radiation for Sarcoma (4 ml Dose) |
| NCT03300544 results posted | NCI-2016-01844 NCI-2016-01844, NCI10058 | Ph 1 | terminated | Talimogene Laherparepvec, Chemotherapy, and Radiation Therapy Before Surgery in Treating Patients With Locally Advanced or Metastatic Rectal Cancer |
| NCT01740297 results posted | 20110264 2012-000307-32 | Ph 1, Ph 2 | completed | Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma |
| NCT03256344 results posted | 20140299 | Ph 1 | completed | Study of Talimogene Laherparepvec With Atezolizumab for Triple Negative Breast Cancer and Colorectal Cancer With Liver Metastases |
| NCT03842943 | 181095 | Ph 2 | recruiting | Neoadjuvant Combination Immunotherapy for Stage III Melanoma |
| NCT02756845 results posted | 20110261 2015-003645-25 | Ph 1 | completed | Study of Talimogene Laherparepvec In Children With Advanced Non CNS Tumors |
| NCT04185311 | 18-000427 NCI-2018-01410, Glaspy BMS CA209-9ET Breast | Ph 1 | terminated | Ipilimumab, Nivolumab, and Talimogene Laherparepvec Before Surgery in Treating Participants With Localized, Triple-Negative or Estrogen Receptor Positive, HER2 Negative Breast Cancer-deleted |
| NCT03064763 results posted | 20140270 | Ph 1 | completed | Study to Evaluate the Safety/ Efficacy of T-VEC in Japanese Subjects With Unresectable Stage IIIB-IV Malignant Melanoma |
| NCT02211131 results posted | 20110266 2014-001146-13 | Ph 2 | completed | Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma |
| NCT02658812 results posted | 2014-0034 NCI-2016-00199, 2014-0034 | Ph 2 | terminated | Talimogene Laherparepvec in Treating Patients With Recurrent Breast Cancer That Cannot Be Removed by Surgery |
| NCT02263508 MASTERKEY-265 results posted | 20110265 2014-000185-22, KEYNOTE-034 | Ph 3 | terminated | Pembrolizumab With Talimogene Laherparepvec or Placebo in Unresected Melanoma |
| NCT02366195 TVEC-325 results posted | 20120325 2013-005552-15 | Ph 2 | completed | Single-arm Trial to Evaluate the Role of the Immune Response to Talimogene Laherparepvec in Unresected Melanoma |
| NCT02626000 MASTERKEY232 results posted | 20130232 20130232 / KEYNOTE-137, 2015-003011-38 | Ph 1 | completed | Talimogene Laherparepvec With Pembrolizumab for Recurrent Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY232 / KEYNOTE-137) |
| NCT03430687 | 15521 NCI-2018-00109, 15-17558 | Ph 1 | withdrawn | Talimogene Laherparepvec in Treating Patients With Non-Muscle Invasive Bladder Transitional Cell Carcinoma |
| NCT02014441 results posted | 20120324 | Ph 2 | completed | Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec |
| NCT00769704 results posted | 005/05 20110263, 2008-006140-20 | Ph 3 | completed | Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma |
| NCT01161498 results posted | 006/09 20110130 | Ph 3 | terminated | Study of Safety and Efficacy of Talimogene Laherparepvec With Cisplatin and Radiotherapy for Treatment of Locally Advanced Head and Neck Cancer |
| NCT01368276 results posted | 005/05-E 2010-021070-11, 20110279 | Ph 3 | completed | An Extended Use Study of Safety and Efficacy of Talimogene Laherparepvec in Melanoma |
| NCT02574260 results posted | 002/03-E | Ph 2 | completed | An Extension Protocol for the Extended Use of Talimogene Laherparepvec for Eligible Patients Who Participated in Study 002/03 (NCT00289016) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
Imlygic FDA Label Details
Indications & Usage
IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve ove...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.