Obinutuzumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2013
- First approval year
- 2013
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Obinutuzumab
- gazyvaro
- Gazyvaro
- afutuzumab
- AFUTUZUMAB
- ga 101
- GA 101
- GA-101
- ga101
- Ga101
- GA101
- GA101 (Obinutuzumab)
- gazyva
- Gazyva
- Gazyvaro
- humab cd20
- HUMAB CD20
- HUMAB<CD20>
- humabcd20
- HUMABCD20
- immunoglobulin g1 anti human cd20 antigen human mouse monoclonal ga101 heavy chain disulfide with human mouse monoclonal ga101 kappa chain dimer
- immunoglobulin g1 anti human cd20 antigen human mouse monoclonal ga101 heavy chain disulphide with human mouse monoclonal ga101 kappa chain dimer
- IMMUNOGLOBULIN G1, ANTI-(HUMAN CD20 (ANTIGEN)) (HUMAN-MOUSE MONOCLONAL GA101 HEAVY CHAIN), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL GA101 .KAPPA.-CHAIN, DIMER
- IMMUNOGLOBULIN G1, ANTI-(HUMAN CD20 (ANTIGEN)) (HUMAN-MOUSE MONOCLONAL GA101 HEAVY CHAIN), DISULPHIDE WITH HUMAN-MOUSE MONOCLONAL GA101 .KAPPA.-CHAIN, DIMER
- obinutuzumab
- Obinutuzumab
- obinutuzumab (RO5072759)
- obinutuzumab [INN]
And 31 more, listed on the interactive page.
- ATC classification codes
- L01FA03
Sources for recorded values
- CAS registry numbers
- 949142-50-1
- ChEMBL ID
- CHEMBL1743048
- RxNorm IDs (RxCUI)
- 974779
- FDA ingredient codes (UNII)
- O43472U9X8
- Applicant
- GENENTECH
- Approval date
- 1 Nov 2013
- Application number
- BLA125486
- Status
- Authorised
- Status date
- 22 Jul 2014
- Authorisation date
- 22 Jul 2014
- Approved indications
- Chronic lymphocytic leukaemia (CLL) Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy. Follicular Lymphoma (FL) Gazyvaro in combination with chemotherapy, followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma. Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. Lupus nephritis (LN) Gazyvaro in combination with mycophenolate mofetil (MMF) is indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN).
- Product number
- EMEA/H/C/002799
- Authorisation holder
- Roche Registration GmbH
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Leukemia, Lymphocytic, Chronic, B-Cell
European medicines record
- Patents
- 0
- Designations
- 5
- Earliest recorded loss of exclusivity
- 16 Nov 2024
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- obinutuzumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Action type
- BINDING_AGENT
- Target
- B-lymphocyte antigen CD20
- Protein identifier
- P11836
- Action
- Binding
- Action type
- Binding
- Target
- CD20 (membrane-spanning 4-domains, subfamily A, member 1)
- Gene symbol
- MS4A1
- Protein identifier
- P11836
- Primary target
- Yes
Open Targets mechanisms
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Action type
- BINDING AGENT
- Target
- B-lymphocyte antigen CD20
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Hodgkin Disease
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Lymphoma, B-Cell, Marginal Zone
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000191
- Subject identifier
- D018442
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Burkitt Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000309
- Subject identifier
- D002051
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Leukemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Lymphoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Lymphoma, T-Cell, Cutaneous
- Highest recorded phase
- 1
- Condition identifier
- EFO:0002913
- Subject identifier
- D016410
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Kidney Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003086
- Subject identifier
- D007674
- Condition
- Glomerulosclerosis, Focal Segmental
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004236
- Subject identifier
- D005923
- Condition
- Nephrotic Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004255
- Subject identifier
- D009404
- Condition
- Leukemia, Lymphoid
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004289
- Subject identifier
- D007945
- Condition
- Lupus Nephritis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005761
- Subject identifier
- D008181
- Condition
- Lymphoma, Non-Hodgkin
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005952
- Subject identifier
- D008228
- Condition
- Purpura, Thrombocytopenic, Idiopathic
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007160
- Subject identifier
- D016553
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0008528
- Subject identifier
- D001749
- Condition
- Waldenstrom Macroglobulinemia
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009441
- Subject identifier
- D008258
- Condition
- Lymphoma, B-Cell, Marginal Zone
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000630
- Subject identifier
- D018442
- Condition
- Leukemia, Hairy Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000956
- Subject identifier
- D007943
- Condition
- Mycosis Fungoides
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001051
- Subject identifier
- D009182
- Condition
- Lymphoma, Mantle-Cell
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001469
- Subject identifier
- D020522
And 8 more, listed on the interactive page.
- Condition identifier
- EFO_0000095
- Condition identifier
- EFO_0000096
- Condition identifier
- EFO_0000220
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000403
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000565
- Condition identifier
- EFO_0000574
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0003086
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004236
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004254
- Condition identifier
- EFO_0005297
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005952
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007160
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009441
- Highest recorded phase
- 2
- Condition identifier
- EFO_0009909
- Highest recorded phase
- 1
- Condition identifier
- EFO_1000157
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000630
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001469
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001938
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001023
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0002083
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002462
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002571
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004948
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004949
- Highest recorded phase
- 2
And 41 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Effect
- infectious disease
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- infectious disease
- Country
- United States
- Event
- b-cell lymphoma recurrent
- Reports
- 36
- Reporting signal score
- 139.242
- Event
- chills
- Reports
- 264
- Reporting signal score
- 267.535
- Event
- chronic lymphocytic leukaemia recurrent
- Reports
- 24
- Reporting signal score
- 71.8587
- Event
- covid-19
- Reports
- 257
- Reporting signal score
- 419.744
- Event
- covid-19 pneumonia
- Reports
- 65
- Reporting signal score
- 158.572
- Event
- cytokine release syndrome
- Reports
- 126
- Reporting signal score
- 303.285
- Event
- cytomegalovirus chorioretinitis
- Reports
- 35
- Reporting signal score
- 91.048
- Event
- cytomegalovirus infection
- Reports
- 94
- Reporting signal score
- 146.439
- Event
- cytopenia
- Reports
- 83
- Reporting signal score
- 157.015
- Event
- disease progression
- Reports
- 138
- Reporting signal score
- 71.9759
- Event
- drug interaction
- Reports
- 2
- Reporting signal score
- 75.5749
- Event
- end stage renal disease
- Reports
- 73
- Reporting signal score
- 175.841
- Event
- febrile neutropenia
- Reports
- 399
- Reporting signal score
- 647.631
- Event
- follicular lymphoma
- Reports
- 32
- Reporting signal score
- 145.5
- Event
- hypogammaglobulinaemia
- Reports
- 65
- Reporting signal score
- 143.879
- Event
- infusion related reaction
- Reports
- 535
- Reporting signal score
- 1,083.75
- Event
- injection site pain
- Reports
- 2
- Reporting signal score
- 74.0839
- Event
- lymphocyte count decreased
- Reports
- 95
- Reporting signal score
- 128.437
- Event
- myelosuppression
- Reports
- 173
- Reporting signal score
- 423.898
- Event
- neutropenia
- Reports
- 524
- Reporting signal score
- 619.36
- Event
- neutrophil count decreased
- Reports
- 137
- Reporting signal score
- 150.714
- Event
- pancytopenia
- Reports
- 134
- Reporting signal score
- 108.867
- Event
- platelet count decreased
- Reports
- 151
- Reporting signal score
- 72.0171
- Event
- post-acute covid-19 syndrome
- Reports
- 24
- Reporting signal score
- 109.031
- Event
- pyrexia
- Reports
- 416
- Reporting signal score
- 180.069
And 3 more, listed on the interactive page.
- NCT00517530
- NCT01414855
- NCT01889797
- NCT01992653
- NCT02220842
- NCT02257567
- NCT02529852
- NCT02670317
- NCT02729896
- NCT02750670
- NCT03039114
- NCT03492125
- NCT04073147
- NCT04464798
- NCT04657302
- NCT06084936
- NCT06213311
- NCT00576758
- NCT00825149
- NCT01059630
- NCT01332968
- NCT02055820
- NCT02453087
- NCT02499003
- NCT02611323
And 185 more, listed on the interactive page.
- Dose
- 100 mg, 900 mg, 1,000 mg
- Route
- Intravenous
- How often
- See details for each condition
- Administer only as infusion
- Do not administer as push or bolus
- Monitor for infusion reactions
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QVQLVQSGAEVKKPGSSVKVSCKASGYAFSYSWINWVRQAPGQGLEWMGRIFPGDGDTDYNGKFKGRVTITADKSTSTAYMELSSLRSEDTAVYYCARNVFDGYWLVYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain
- Type
- Protein
- Sequence
- DIVMTQTPLSLPVTPGEPASISCRSSKSLLHSNGITYLYWYLQKPGQSPQLLIYQMSNLVSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCAQNLELPYTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 50242-070
Related records
Trials (319)
- A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-cell Non-hodgkin's Lymphoma
- A Dose Finding and Safety Study of CC-220, Alone and in Combination With an Anti-CD20 Monoclonal Antibody (mAb) in Subjects With Relapsed or Refractory Lymphomas
- A Dose-Escalating Study of Obinutuzumab in Patients With B-lymphocyte Antigen (CD20+) Malignant Disease (GAUGUIN)
- A Dose-Finding and Efficacy Study of Venetoclax, CC-486, and Obinutuzumab in Follicular Lymphoma
- A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
- A Multicenter Phase 2 Single-arm Proof-of-concept Trial Assessing the Efficacy and Safety of Obinutuzumab in the Treatment of Non-infectious Active Cryoglobulinemia Vasculitis Refractory or Intolerant to Rituximab
- A Multicenter, Prospective, Open-Label, Randomized Controlled Clinical Study of Orelabrutinib Combined With Obinutuzumab and Lenalidomide Versus Obinutuzumab Plus Chemotherapy for Treatment-Naive Follicular Lymphoma
- A Phase 1 Study of Acalabrutinib in Japanese Adult Patients With Advanced B-cell Malignancies
- A Phase 1/2, Open-label, Dose Finding Study to Evaluate CC-122 in Combination With Ibrutinib and Obinutuzumab in Subjects With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- A Phase 1b Open-label Study to Evaluate the Safety and Efficacy of CC-122 With Obinutuzumab (GA101) in Relapsed/Refractory DLBCL and iNHL.
- A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure.
- A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia
- A PHASE I STUDY OF ALPS12 IN PATIENTS WITH EXTENSIVE STAGE SMALL CELL LUNG CANCER
- A Phase I/II Study of Lenalidomide and Obinutuzumab With CHOP for Diffuse Large B Cell Lymphoma
- A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma
- A Phase II Study of the BRAF Inhibitor, Vemurafenib, Plus Obinutuzumab in Patients With Previously Untreated Classical Hairy Cell Leukemia
- A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL
- A Prospective Cohort of Obinutuzumab and Chlorambucil (GC) Chemotherapy for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia Including Next- Generation Sequencing (NGS)-Based Assessment
- A Prospective Multicenter Phase 2 Study of the Chemotherapy-Free Combination of the Intravenous Phosphatidylinositol-3-Kinase (PI3K) Inhibitor Copanlisib in Combination With Obinutuzumab in Patients With Previously Untreated Follicular Lymphoma (FL) and a High Tumor Burden
Approved for (5)
- B-cell chronic lymphocytic leukemia
- Cancer
- Follicular lymphoma
- Neoplasm
- Neoplasm of mature B-cells
In development for (32)
- Acute lymphoblastic leukemia Phase 2
- Autoimmune thrombocytopenic purpura Phase 2
- B-cell non-Hodgkin lymphoma Phase 2
- Burkitt lymphoma Phase 1
- Chronic renal failure syndrome Phase 1
- Colorectal cancer Phase 1
- Diffuse large B-cell lymphoma Phase 3
- Focal segmental glomerulosclerosis Phase 2
- Glomerulonephritis Phase 2
- Graft versus host disease Phase 2
- Granulomatosis with polyangiitis Phase 2
- Hairy cell leukemia Phase 2
- Hodgkins lymphoma Phase 1
- Kidney disorder Phase 3
- Leukemia Phase 2
- Lupus nephritis Phase 3
- Lymphoid leukemia Phase 2
- Lymphoma Phase 3
- MALT lymphoma Phase 2
- Mantle cell lymphoma Phase 2
Other linked conditions (2)
- Idiopathic membranous glomerulonephritis
- Membranous glomerulonephritis
Targets (1)
- MS4A1 B-lymphocyte antigen CD20 binding agent