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| Stem definition | Drug id | CAS RN |
|---|---|---|
| chimeric origin | 5691 | 1453084-37-1 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Mirvetuximab soravtansine-gynx is an antibody-drug conjugate (ADC). The antibody is a chimeric IgG1 directed against folate receptor alpha (FRalpha). The small molecule, DM4, is a microtubule inhibitor attached to the antibody via a cleavable linker. Upon binding to FRalpha, mirvetuximab soravtansine-gynx is internalized followed by intracellular release of DM4 via proteolytic cleavage. DM4 disrupts the microtubule network within the cell, resulting in cell cycle arrest and apoptotic cell death.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 14, 2022 | FDA | IMMUNOGEN INC |
| 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 |
|---|---|---|---|---|---|---|
| Keratopathy | 235.62 | 44.04 | 33 | 1216 | 675 | 90626523 |
| Keratitis | 172.06 | 44.04 | 32 | 1217 | 3974 | 90623224 |
| Pneumonitis | 120.27 | 44.04 | 38 | 1211 | 44132 | 90583066 |
| Disease progression | 85.47 | 44.04 | 42 | 1207 | 156573 | 90470625 |
| Ocular toxicity | 81.98 | 44.04 | 14 | 1235 | 1063 | 90626135 |
| Death | 78.21 | 44.04 | 58 | 1191 | 456493 | 90170705 |
| Neuropathy peripheral | 72.49 | 44.04 | 36 | 1213 | 136934 | 90490264 |
| Abdominal pain | 67.05 | 44.04 | 50 | 1199 | 395671 | 90231527 |
| Cataract | 60.13 | 44.04 | 26 | 1223 | 72066 | 90555132 |
| Vision blurred | 58.33 | 44.04 | 29 | 1220 | 110264 | 90516934 |
| Thrombocytopenia | 48.31 | 44.04 | 32 | 1217 | 208693 | 90418505 |
| Punctate keratitis | 44.77 | 44.04 | 8 | 1241 | 788 | 90626410 |
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| 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 |
|---|---|---|---|---|---|---|
| Keratitis | 69.38 | 55.27 | 13 | 489 | 5131 | 110583666 |
| Keratopathy | 63.91 | 55.27 | 10 | 492 | 1363 | 110587434 |
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| Source | Code | Description |
|---|---|---|
| ATC | L01FX26 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES Other monoclonal antibodies and antibody drug conjugates |
| MeSH PA | D000074322 | Antineoplastic Agents, Immunological |
| MeSH PA | D000970 | Antineoplastic Agents |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| FRalpha positive platinum-resistant epithelial ovarian cancer | indication | 254849005 | |
| FRalpha positive platinum-resistant fallopian tube cancer | indication | 363444001 | DOID:1964 |
| FRalpha positive platinum-resistant primary peritoneal cancer | indication | 363492001 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Folate receptor alpha | Membrane receptor | BINDING AGENT | Kd | 10.12 | DRUG LABEL | DRUG LABEL |
| ID | Source |
|---|---|
| CHEBI:755477 | CHEBI |
| CHEMBL3545132 | ChEMBL_ID |
| C000607289 | MESH_SUPPLEMENTAL_RECORD_UI |
| 12250 | IUPHAR_LIGAND_ID |
| DB12489 | DRUGBANK_ID |
| 4041843 | VANDF |
| 4041844 | VANDF |
| C4288736 | UMLSCUI |
| 10176 | INN_ID |
| D10954 | KEGG_DRUG |
| 91810695 | PUBCHEM_CID |
| 363141 | MMSL |
| 41058 | MMSL |
| d09944 | MMSL |
| 019225 | NDDF |
| 98DE7VN88D | UNII |
| 2621548 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ELAHERE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72903-853 | INJECTION, SOLUTION | 5 mg | INTRAVENOUS | BLA | 33 sections |