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| Stem definition | Drug id | CAS RN |
|---|---|---|
| monoclonal antibodies (humanized origin); tumor | 5700 | 1905409-39-3 |
| Molecule | Description |
|---|---|
|
Synonyms:
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Mosunetuzumab is an anti-CD20/CD3 T-cell engaging bispecific antibody targeting CD20-expressing B-cells. It is a conditional agonist; targeted B-cell killing is observed only upon simultaneous binding to CD20 on B-cells and CD3 on T-cells. Engagement of both arms of mosunetuzumab results in the formation of an immunologic synapse between a target B cell and a cytotoxic T cell leading to T-cell activation. Subsequent directed release of perforin and granzymes from T-cell activation through the immunologic synapsis induce B-cell lysis leading to cell death.
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| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 3, 2022 | EMA | Roche Registration GmbH | |
| Dec. 22, 2022 | FDA | GENENTECH 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 |
|---|---|---|---|---|---|---|
| Cytokine release syndrome | 377.64 | 75.08 | 77 | 644 | 27896 | 90599830 |
| Vasogenic cerebral oedema | 178.26 | 75.08 | 26 | 695 | 1264 | 90626462 |
| Disease progression | 164.38 | 75.08 | 57 | 664 | 156558 | 90471168 |
| Neurological symptom | 134.90 | 75.08 | 26 | 695 | 6821 | 90620905 |
| Diffuse large B-cell lymphoma recurrent | 131.71 | 75.08 | 23 | 698 | 3503 | 90624223 |
| Disorientation | 86.75 | 75.08 | 26 | 695 | 44088 | 90583638 |
| Therapy partial responder | 84.81 | 75.08 | 22 | 699 | 22021 | 90605705 |
| 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 |
|---|---|---|---|---|---|---|
| Cytokine release syndrome | 215.65 | 58.14 | 57 | 432 | 44470 | 42576376 |
| COVID-19 | 81.97 | 58.14 | 35 | 454 | 115913 | 42504933 |
| COVID-19 pneumonia | 64.05 | 58.14 | 19 | 470 | 21594 | 42599252 |
| 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 |
|---|---|---|---|---|---|---|
| Cytokine release syndrome | 517.21 | 60.04 | 126 | 1147 | 70180 | 110517846 |
| Disease progression | 182.96 | 60.04 | 77 | 1196 | 243957 | 110344069 |
| Vasogenic cerebral oedema | 153.90 | 60.04 | 26 | 1247 | 2232 | 110585794 |
| COVID-19 pneumonia | 124.52 | 60.04 | 36 | 1237 | 37107 | 110550919 |
| Diffuse large B-cell lymphoma recurrent | 109.75 | 60.04 | 23 | 1250 | 6276 | 110581750 |
| Neurological symptom | 103.79 | 60.04 | 26 | 1247 | 15582 | 110572444 |
| Neutropenia | 103.53 | 60.04 | 60 | 1213 | 374560 | 110213466 |
| COVID-19 | 100.38 | 60.04 | 51 | 1222 | 245009 | 110343017 |
| Malignant neoplasm progression | 76.23 | 60.04 | 38 | 1235 | 174529 | 110413497 |
| Disorientation | 65.14 | 60.04 | 26 | 1247 | 70645 | 110517381 |
| Therapy partial responder | 61.42 | 60.04 | 21 | 1252 | 37040 | 110550986 |
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| Source | Code | Description |
|---|---|---|
| ATC | L01FX25 | 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 |
|---|---|---|---|
| Relapsed or refractory follicular lymphoma | indication | 55150002 |
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| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| B-lymphocyte antigen CD20 | Surface antigen | UNKNOWN | DRUG LABEL |
| ID | Source |
|---|---|
| CHEBI:757234 | CHEBI |
| CHEMBL4297788 | ChEMBL_ID |
| C000731929 | MESH_SUPPLEMENTAL_RECORD_UI |
| 12298 | IUPHAR_LIGAND_ID |
| DB15434 | DRUGBANK_ID |
| 278181000202107 | SNOMEDCT_US |
| 4041943 | VANDF |
| C4763385 | UMLSCUI |
| 10621 | INN_ID |
| D11463 | KEGG_DRUG |
| 364475 | MMSL |
| 41159 | MMSL |
| d09958 | MMSL |
| 019149 | NDDF |
| LDJ89SS0YG | UNII |
| 2625122 | RXNORM |
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Lunsumio | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-142 | CONCENTRATE | 30 mg | INTRAVENOUS | BLA | 31 sections |
| Lunsumio | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-159 | CONCENTRATE | 1 mg | INTRAVENOUS | BLA | 31 sections |
| Lunsumio Velo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-177 | INJECTION | 5 mg | SUBCUTANEOUS | BLA | 30 sections |
| Lunsumio Velo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-201 | INJECTION | 45 mg | SUBCUTANEOUS | BLA | 30 sections |