Overview
Obinutuzumab is a humanized monoclonal antibody used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia. It was approved by the FDA in November 2013 and is marketed under the brand name Gazyva. There is a black box warning of fatal Hepatitis B Virus (HBV) reactivation and fatal Progressive Multifocal Leukoencephalopathy (PML).
Background
Obinutuzumab is a humanized monoclonal antibody used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia. It was approved by the FDA in November 2013 and is marketed under the brand name Gazyva. There is a black box warning of fatal Hepatitis B Virus (HBV) reactivation and fatal Progressive Multifocal Leukoencephalopathy (PML).
Indication
Obinutuzumab is used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia.
Associated Conditions
- Refractory Follicular Lymphoma
- Previously untreated Chronic lymphocytic leukemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/04 | Phase 2 | Not yet recruiting | |||
2025/06/04 | Phase 2 | Not yet recruiting | |||
2025/05/18 | Phase 2 | Not yet recruiting | Zulfa Omer | ||
2025/05/13 | Phase 2 | Not yet recruiting | |||
2025/05/08 | Phase 2 | Not yet recruiting | Sun Yat-sen University | ||
2025/04/24 | Phase 3 | Recruiting | |||
2025/04/23 | Phase 2 | Not yet recruiting | |||
2025/04/10 | Phase 1 | Not yet recruiting | City of Hope Medical Center | ||
2025/04/08 | Phase 1 | Not yet recruiting | Paolo Caimi, MD | ||
2025/02/27 | Phase 2 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Genentech, Inc. | 50242-070 | INTRAVENOUS | 1000 mg in 40 mL | 8/23/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/22/2014 | ||
Authorised | 7/22/2014 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| GAZYVA CONCENTRATE FOR SOLUTION FOR INFUSION 1000MG/40ML | SIN14827P | INFUSION, SOLUTION CONCENTRATE | 1000 mg/40 mL | 8/13/2015 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Obinutuzumab Injection | 国药准字SJ20210018 | 生物制品 | 注射剂 | 6/1/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| GAZYVA CONCENTRATE FOR SOLUTION FOR INFUSION 1000MG/40ML | N/A | N/A | N/A | 10/29/2015 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| GAZYVA obinutuzumab (rch) 1000 mg/40 mL concentrate solution for infusion vial | 210562 | Medicine | A | 5/15/2014 |