Imlygic(talimogene laherparepvec)
Imlygic (talimogene laherparepvec) is a gene pharmaceutical. Talimogene laherparepvec was first approved as Imlygic on 2015-10-27. It is used to treat melanoma in the USA. It has been approved in Europe to treat melanoma.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Imlygic
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| imlygic | Biologic Licensing Application | 2025-04-04 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
talimogene laherparepvec, Imlygic, Amgen Inc. | |||
| 2122-10-27 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9325 | Injection, talimogene laherparepvec, per 1 million plaque forming units |
Clinical
Clinical Trials
54 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | — | 3 | 8 | 2 | — | 3 | 15 |
| Carcinoma | D002277 | — | C80.0 | 4 | 2 | 1 | — | — | 6 |
| Squamous cell carcinoma | D002294 | — | — | 1 | 1 | 1 | — | — | 3 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | 1 | — | — | 2 |
| Squamous cell neoplasms | D018307 | — | — | — | 1 | 1 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 1 | — | — | — | 4 |
| Sarcoma | D012509 | — | — | 2 | 4 | — | — | — | 4 |
| Neoplasms | D009369 | — | C80 | 2 | 2 | — | — | — | 3 |
| Triple negative breast neoplasms | D064726 | — | — | 2 | 1 | — | — | — | 2 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | 2 | 1 | — | — | — | 2 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | 1 | — | — | — | 1 |
| Pleural effusion | D010996 | — | J90 | 1 | 1 | — | — | — | 1 |
| Malignant pleural effusion | D016066 | — | J91.0 | 1 | 1 | — | — | — | 1 |
| Ductal carcinoma breast | D018270 | — | — | 1 | 1 | — | — | — | 1 |
| Ductal carcinoma | D044584 | — | — | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 1 | — | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | — | 1 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | — | — | 1 |
| Transitional cell carcinoma | D002295 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 1 | 1 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 1 | 1 |
| Herpes simplex | D006561 | — | B00 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Talimogene laherparepvec |
| INN | talimogene laherparepvec |
| Description | Talimogene laherparepvec, sold under the brand name Imlygic, is a biopharmaceutical medication used to treat melanoma that cannot be operated on; it is injected directly into a subset of lesions which generates a systemic immune response against the recipient's cancer. The final four year analysis from the pivotal phase 3 study upon which TVEC was approved by the FDA showed a 31.5% response rate with a 16.9% complete response (CR) rate. There was also a substantial and statistically significant survival benefit in patients with earlier metastatic disease (stages IIIb-IVM1a) and in patients who hadn't received prior systemic treatment for melanoma. The earlier stage group had a reduction in the risk of death of approximately 50% with one in four patients appearing to have met, or be close to be reaching, the medical definition of cure. Real world use of talimogene laherparepvec have shown response rates of up to 88.5% with CR rates of up to 61.5%.
|
| Classification | Gene |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1187560-31-1 |
| RxCUI | 1721264 |
| ChEMBL ID | CHEMBL2108727 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB13896 |
| UNII ID | 07730V90L6 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
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Adverse Events
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1,394 adverse events reported
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