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AboutPricing
Drug ReportsTalimogene laherparepvec
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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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
skin and connective tissue diseasesD017437
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
ImlygicTalimogene laherparepvecAmgenA-125518 RX2015-10-27
2 products
ImlygicTalimogene laherparepvecAmgenN-125518 RX2015-10-27
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
imlygicBiologic Licensing Application2025-04-04
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
melanoma—D008545—
Agency Specific
FDA
EMA
Expiration
Code
talimogene laherparepvec, Imlygic, Amgen Inc.
2122-10-27Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XL: Antineoplastic cell and gene therapy agents
— L01XL02: Talimogene laherparepvec
HCPCS
Code
Description
J9325
Injection, talimogene laherparepvec, per 1 million plaque forming units
Clinical
Clinical Trials
55 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD008545——6144—325
CarcinomaD002277—C80.0521——8
Squamous cell carcinomaD002294——321——6
Squamous cell neoplasmsD018307——321——6
Skin neoplasmsD012878EFO_0004198C44111——3
Head and neck neoplasmsD006258——1—1——2
Cutaneous malignant melanomaD000096142————1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcomaD012509——37———8
Breast neoplasmsD001943EFO_0003869C5062———7
NeoplasmsD009369—C8043———6
Neoplasm metastasisD009362EFO_0009708—23———4
Merkel cell carcinomaD015266EFO_1001471C4A22———4
Triple negative breast neoplasmsD064726——31———3
Invasive hydatidiform moleD002820—D39.231———3
Mycosis fungoidesD009182—C84.011———2
Basal cell carcinomaD002280——11———2
T-cell lymphoma cutaneousD016410—C84.A11———2
Show 29 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C252————2
Colorectal neoplasmsD015179——1————1
MycosesD009181—B35-B491————1
Renal cell carcinomaD002292EFO_0000376—1————1
Rectal neoplasmsD012004——1————1
Breast carcinoma in situD000071960—D051————1
Squamous cell carcinoma of head and neckD000077195——1————1
Peritoneal neoplasmsD010534——1————1
Basal cell neoplasmsD018295——1————1
Transitional cell carcinomaD002295——1————1
Show 3 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Herpes simplexD006561—B00————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTalimogene laherparepvec
INNtalimogene 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)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1187560-31-1
RxCUI1721264
ChEMBL IDCHEMBL2108727
ChEBI ID—
PubChem CID—
DrugBankDB13896
UNII ID07730V90L6 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 4,621 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,592 adverse events reported
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