| Stem definition | Drug id | CAS RN |
|---|---|---|
| antitumor, monoclonal antibodies | 5463 | 2171511-58-1 |
| Molecule | Description |
|---|---|
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Synonyms:
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Amivantamab-vmjw is a bispecific antibody that binds to the extracellular domains of EGFR and MET. In in vitro and in vivo studies amivantamab-vmjw was able to disrupt EGFR and MET signaling functions through blocking ligand binding and, in exon 20 insertion mutation models, degradation of EGFR and MET. The presence of EGFR and MET on the surface of tumor cells also allows for targeting of these cells for destruction by immune effector cells, such as natural killer cells and macrophages, through antibody-dependent cellular cytotoxicity ( ADCC) and trogocytosis mechanisms, respectively.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Sept. 12, 2021 | EMA | Janssen-Cilag International N.V. | |
| May 21, 2021 | FDA | JANSSEN BIOTECH |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infusion related reaction | 96.97 | 48.21 | 40 | 328 | 245481 | 63243173 |
| Paronychia | 53.35 | 48.21 | 11 | 357 | 5554 | 63483100 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infusion related reaction | 96.86 | 65.43 | 28 | 202 | 53029 | 34903672 |
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Infusion related reaction | 80.78 | 45.43 | 36 | 488 | 230201 | 79513663 |
| Pulmonary embolism | 63.76 | 45.43 | 28 | 496 | 171626 | 79572238 |
| Dermatitis acneiform | 50.70 | 45.43 | 12 | 512 | 9981 | 79733883 |
| Pneumonitis | 47.41 | 45.43 | 17 | 507 | 60843 | 79683021 |
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| Source | Code | Description |
|---|---|---|
| ATC | L01FX18 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES Other monoclonal antibodies and antibody drug conjugates |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D000074322 | Antineoplastic Agents, Immunological |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations | indication | 703228009 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Epidermal growth factor receptor | Kinase | ANTIBODY BINDING | Kd | 8.84 | DRUG LABEL | DRUG LABEL | |||
| Hepatocyte growth factor receptor | Kinase | ANTIBODY BINDING | Kd | 10.40 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| 0JSR7Z0NB6 | UNII |
| D11894 | KEGG_DRUG |
| C5446297 | UMLSCUI |
| CHEMBL4297774 | ChEMBL_ID |
| DB16695 | DRUGBANK_ID |
| 11030 | INN_ID |
| C000718215 | MESH_SUPPLEMENTAL_RECORD_UI |
| 10505 | IUPHAR_LIGAND_ID |
| 018739 | NDDF |
| 1162751008 | SNOMEDCT_US |
| 1162897004 | SNOMEDCT_US |
| 4040533 | VANDF |
| 4040534 | VANDF |
| 2549198 | RXNORM |
| 346603 | MMSL |
| 39540 | MMSL |
| d09748 | MMSL |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Rybrevant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57894-501 | INJECTION | 350 mg | INTRAVENOUS | BLA | 29 sections |
| Rybrevant | HUMAN PRESCRIPTION DRUG LABEL | 1 | 57894-501 | INJECTION | 350 mg | INTRAVENOUS | BLA | 29 sections |