Gazyva, Gazyvaro(obinutuzumab)
Gazyva, Gazyvaro (obinutuzumab) is an antibody pharmaceutical. Obinutuzumab was first approved as Gazyva on 2013-11-01. It is used to treat follicular lymphoma and lymphoid leukemia in the USA. It has been approved in Europe to treat b-cell chronic lymphocytic leukemia. The pharmaceutical is active against B-lymphocyte antigen CD20.
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Gazyva
Drug Products
FDA
EMA
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| gazyva | Biologic Licensing Application | 2023-08-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| follicular lymphoma | — | D008224 | C82 |
| lymphoid leukemia | — | D007945 | C91 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
obinutuzumab, Gazyva, Genentech, Inc. | |||
| 2024-11-16 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9301 | Injection, obinutuzumab, 10 mg |
Clinical
Clinical Trials
328 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 2 | 9 | 8 | — | 3 | 22 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 13 | 12 | 2 | — | — | 20 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 9 | 9 | 3 | — | — | 16 |
| Lymphoid leukemia | D007945 | — | C91 | 2 | 4 | 7 | — | 3 | 16 |
| Leukemia | D007938 | — | C95 | 1 | 3 | 7 | — | 3 | 14 |
| B-cell lymphoma | D016393 | — | — | 5 | 4 | 2 | — | — | 9 |
| Lupus nephritis | D008181 | EFO_0005761 | — | — | 2 | 2 | — | — | 4 |
| Membranous glomerulonephritis | D015433 | EFO_0004254 | N03.2 | — | 2 | 2 | — | — | 3 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | — | — | 2 | — | — | 2 |
| Nephritis | D009393 | — | N05 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mantle-cell lymphoma | D020522 | — | C83.1 | 2 | 4 | — | — | — | 4 |
| Recurrence | D012008 | — | — | 3 | 3 | — | — | — | 3 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | — | 1 | — | — | — | 1 |
| Waldenstrom macroglobulinemia | D008258 | — | C88.0 | — | 1 | — | — | — | 1 |
| Graft vs host disease | D006086 | — | D89.81 | — | 1 | — | — | — | 1 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | — | — | — | 1 |
| Reactive arthritis | D016918 | EFO_0007460 | M02.3 | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 2 | — | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 2 | — | — | — | — | 2 |
| Adenocarcinoma | D000230 | — | — | 1 | — | — | — | — | 1 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
| Uveal neoplasms | D014604 | EFO_1001230 | — | 1 | — | — | — | — | 1 |
| Cutaneous malignant melanoma | D000096142 | — | — | 1 | — | — | — | — | 1 |
| Uveal melanoma | D000098943 | — | — | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Obinutuzumab |
| INN | obinutuzumab |
| Description | Obinutuzumab (humanized mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >6Y9A:H|Obinutuzumab Fab heavy chain
VQLVQSGAEVKKPGSSVKVSCKASGYAFSYSWINWVRQAPGQGLEWMGRIFPGDGDTDYNGKFKGRVTITADKSTSTAYM
ELSSLRSEDTAVYYCARNVFDGYWLVYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWN
SGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPK
>6Y9A:L|Obinutuzumab Fab Light chain
DIVMTQTPLSLPVTPGEPASISCRSSKSLLHSNGITYLYWYLQKPGQSPQLLIYQMSNLVSGVPDRFSGSGSGTDFTLKI
SRVEAEDVGVYYCAQNLELPYTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQ
SGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
| PDB | 6Y97, 6Y9A |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1743048 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB08935 |
| UNII ID | O43472U9X8 (ChemIDplus, GSRS) |
Target
Agency Approved
MS4A1
MS4A1
Organism
Homo sapiens
Gene name
MS4A1
Gene synonyms
CD20
NCBI Gene ID
Protein name
B-lymphocyte antigen CD20
Protein synonyms
B-lymphocyte cell-surface antigen B1, B-lymphocyte surface antigen B1, Bp35, CD20, CD20 antigen, CD20 receptor, Leukocyte surface antigen Leu-16, Membrane-spanning 4-domains subfamily A member 1, membrane-spanning 4-domains, subfamily A, member 1
Uniprot ID
Mouse ortholog
Ms4a1 (12482)
B-lymphocyte antigen CD20 (P19437)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Additional graphs summarizing 5,918 documents
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Safety
Black-box Warning
Black-box warning for: Gazyva
Adverse Events
Top Adverse Reactions
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14,393 adverse events reported
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