Therapeutic Area | MeSH |
---|---|
neoplasms | D009369 |
skin and connective tissue diseases | D017437 |
Brand Name | Status | Last Update |
---|---|---|
imlygic | Biologic Licensing Application | 2025-04-04 |
Expiration | Code | ||
---|---|---|---|
talimogene laherparepvec, Imlygic, Amgen Inc. | |||
2122-10-27 | Orphan excl. |
Code | Description |
---|---|
J9325 | Injection, talimogene laherparepvec, per 1 million plaque forming units |
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 |
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 |
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 |
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 |
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) | — |
PDB | — |
CAS-ID | 1187560-31-1 |
RxCUI | 1721264 |
ChEMBL ID | CHEMBL2108727 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB13896 |
UNII ID | 07730V90L6 (ChemIDplus, GSRS) |