talimogene laherparepvec 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
gene therapy products 5180 1187560-31-1

Description:

MoleculeDescription

Synonyms:

  • talimogene laherparepvec
  • imlygic
  • JS1 34.5-hGMCSF 47-pA-
  • oncovex
Talimogene laherparepvec is a live, attenuated HSV-1 that has been genetically modified to express huGM-CSF. Talimogene laherparepvec has been genetically modified to replicate within tumors and to produce the immune stimulatory protein GM-CSF and causes lysis of tumors, followed by release of tumor-derived antigens, which together with virally derived GM-CSF may promote an antitumor immune response.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Dec. 16, 2015 EMA Amgen Europe B.V.
Oct. 27, 2015 FDA AMGEN

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Oral herpes 97.99 56.00 26 529 26048 63462419
Pyrexia 56.30 56.00 40 515 470438 63018029

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Off label use 117.81 48.88 78 535 419446 34536872
Influenza like illness 66.68 48.88 23 590 27611 34928707
Pyrexia 64.85 48.88 50 563 332963 34623355
Herpes virus infection 53.97 48.88 12 601 2830 34953488
Melanosis 52.22 48.88 6 607 15 34956303

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Off label use 133.02 47.48 99 875 907116 78836298
Oral herpes 92.19 47.48 27 947 27427 79715987
Melanoma recurrent 78.22 47.48 11 963 261 79743153
Herpes virus infection 67.82 47.48 16 958 7033 79736381
Metastatic malignant melanoma 64.06 47.48 13 961 2850 79740564
Chills 59.84 47.48 32 942 160202 79583212
Herpes simplex 59.12 47.48 16 958 12171 79731243
Melanosis 58.05 47.48 7 967 46 79743368
Influenza like illness 56.61 47.48 24 950 71683 79671731
Pyrexia 52.78 47.48 52 922 678657 79064757

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01XL02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Antineoplastic cell and gene therapy
MeSH PA D000970 Antineoplastic Agents
MeSH PA D000074322 Antineoplastic Agents, Immunological

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Malignant melanoma indication 372244006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

IDSource
07730V90L6 UNII
4035058 VANDF
C1831828 UMLSCUI
CHEMBL2108727 ChEMBL_ID
D09966 KEGG_DRUG
DB13896 DRUGBANK_ID
9402 INN_ID
1721264 RXNORM
236951 MMSL
31270 MMSL
d08394 MMSL
016546 NDDF
717219000 SNOMEDCT_US
763517001 SNOMEDCT_US
C000629782 MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Imlygic HUMAN PRESCRIPTION DRUG LABEL 1 55513-078 INJECTION, SUSPENSION 1000000 [PFU] INTRALESIONAL BLA 32 sections
Imlygic HUMAN PRESCRIPTION DRUG LABEL 1 55513-078 INJECTION, SUSPENSION 1000000 [PFU] INTRALESIONAL BLA 32 sections
Imlygic HUMAN PRESCRIPTION DRUG LABEL 1 55513-078 INJECTION, SUSPENSION 1000000 [PFU] INTRALESIONAL BLA 32 sections
Imlygic HUMAN PRESCRIPTION DRUG LABEL 1 55513-079 INJECTION, SUSPENSION 100000000 [PFU] INTRALESIONAL BLA 32 sections
Imlygic HUMAN PRESCRIPTION DRUG LABEL 1 55513-079 INJECTION, SUSPENSION 100000000 [PFU] INTRALESIONAL BLA 32 sections
Imlygic HUMAN PRESCRIPTION DRUG LABEL 1 55513-079 INJECTION, SUSPENSION 100000000 [PFU] INTRALESIONAL BLA 32 sections