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 |
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)
Talimogene laherparepvec
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Imlygic | Talimogene laherparepvec | Amgen | A-125518 RX | 2015-10-27 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| imlygic | Biologic Licensing Application | 2019-10-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| melanoma | — | D008545 | — |
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
50 clinical trials
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Indications Phases 4
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 5 | 2 | — | — | — | 6 |
| Sarcoma | D012509 | 3 | 5 | — | — | — | 6 | ||
| Merkel cell carcinoma | D015266 | EFO_1001471 | C4A | 2 | 2 | — | — | — | 4 |
| Neoplasms | D009369 | C80 | 2 | 2 | — | — | — | 3 | |
| Invasive hydatidiform mole | D002820 | D39.2 | 3 | 1 | — | — | — | 3 | |
| Mycosis fungoides | D009182 | C84.0 | 1 | 1 | — | — | — | 2 | |
| Keratoacanthoma | D007636 | — | 2 | — | — | — | 2 | ||
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 1 | 1 | — | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | 1 | |
| Lung neoplasms | D008175 | C34.90 | 1 | 1 | — | — | — | 1 |
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Indications Without Phase
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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%.
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| 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
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 2,704 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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559 adverse events reported
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