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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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
301 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 66 | 108 | 16 | 2 | 11 | 169 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 27 | 47 | 22 | 1 | 11 | 101 |
| Lymphoid leukemia | D007945 | — | C91 | 24 | 40 | 20 | 1 | 9 | 87 |
| Leukemia | D007938 | — | C95 | 22 | 36 | 21 | 1 | 9 | 84 |
| Follicular lymphoma | D008224 | — | C82 | 23 | 37 | 6 | 1 | 6 | 59 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 8 | 15 | 2 | 1 | 2 | 25 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma | D016393 | — | — | 33 | 35 | 3 | — | 4 | 61 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 28 | 31 | 2 | — | 2 | 50 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 21 | 28 | 3 | — | 2 | 43 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 8 | 20 | 1 | — | 1 | 25 |
| Syndrome | D013577 | — | — | 1 | 5 | 2 | — | — | 7 |
| Lupus nephritis | D008181 | EFO_0005761 | — | 1 | 2 | 2 | — | — | 5 |
| Nephritis | D009393 | — | N05 | 1 | 2 | 2 | — | — | 5 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | 3 | — | 1 | 5 |
| Membranous glomerulonephritis | D015433 | EFO_0004254 | N03.2 | — | 1 | 3 | — | 1 | 5 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | 1 | — | 2 | — | — | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | 6 | 8 | — | — | — | 11 |
| Neoplasms | D009369 | — | C80 | 8 | 3 | — | — | — | 10 |
| Waldenstrom macroglobulinemia | D008258 | — | C88.0 | 2 | 4 | — | — | 1 | 6 |
| Reactive arthritis | D016918 | EFO_0007460 | M02.3 | 2 | 5 | — | — | — | 6 |
| Burkitt lymphoma | D002051 | — | C83.7 | 3 | 2 | — | — | 1 | 5 |
| Hairy cell leukemia | D007943 | — | C91.4 | 2 | 3 | — | — | — | 4 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | 4 | — | — | — | 4 |
| Colorectal neoplasms | D015179 | — | — | 3 | 1 | — | — | — | 3 |
| Carcinoma | D002277 | — | C80.0 | 3 | 1 | — | — | — | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 2 | — | — | — | 3 |
Show 28 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 2 | — | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | — | — | — | — | 2 |
| T-cell lymphoma | D016399 | — | — | 2 | — | — | — | — | 2 |
| Mycoses | D009181 | — | B35-B49 | 1 | — | — | — | — | 1 |
| Hodgkin disease | D006689 | — | C81 | 1 | — | — | — | — | 1 |
| Mycosis fungoides | D009182 | — | C84.0 | 1 | — | — | — | — | 1 |
| T-cell lymphoma cutaneous | D016410 | — | C84.A | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
Show 16 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | — | 1 | 1 |
| Hepatitis b | D006509 | — | — | — | — | — | — | 1 | 1 |
| Immunosuppression therapy | D007165 | — | — | — | — | — | — | 1 | 1 |
| Hepatitis | D006505 | — | K75.9 | — | — | — | — | 1 | 1 |
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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Safety
Black-box Warning
Black-box warning for: Gazyva
Adverse Events
Top Adverse Reactions
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12,199 adverse events reported
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