Overview
Glofitamab is a full-length bispecific monoclonal antibody with affinity for both CD20 and CD3 surface antigens found on B- and T-cells, respectively. It has a 2:1 configuration, with bivalency towards CD20 and monovalency towards CD3, and works by recruiting T-cells directly to the surface of cancerous B-cells. Glofitamab was approved by Health Canada in March 2023 for the treatment of certain patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), becoming the first CD20/CD3 bispecific monoclonal antibody approved for DLBCL. The most common type of non-Hodgkin lymphoma, DLBCL is relatively sensitive to chemotherapy and generally responsive to first-line treatment regimens like CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) - despite this, as many as 40% of patients will experience relapsed or refractory disease. In the context of relapsed or refractory DLBCL, glofitamab provides an alternative treatment option for patients having failed other systemic therapies or for whom targeted therapies - such as CAR-T cell therapy - are inappropriate. In June 2023, the FDA approved the use of glofitamab for the treatment of patients with relapsed or refractory DLBCL not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy under accelerated approval based on response rate and durability of response. Glofitamab was granted conditional marketing authorization in July 2023 by the EMA for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. This approval is based on the positive results obtained from the phase I/II NP30179 study, where 35.2% of study participants achieved a complete response.
Background
Glofitamab is a full-length bispecific monoclonal antibody with affinity for both CD20 and CD3 surface antigens found on B- and T-cells, respectively. It has a 2:1 configuration, with bivalency towards CD20 and monovalency towards CD3, and works by recruiting T-cells directly to the surface of cancerous B-cells. Glofitamab was approved by Health Canada in March 2023 for the treatment of certain patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), becoming the first CD20/CD3 bispecific monoclonal antibody approved for DLBCL. The most common type of non-Hodgkin lymphoma, DLBCL is relatively sensitive to chemotherapy and generally responsive to first-line treatment regimens like CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) - despite this, as many as 40% of patients will experience relapsed or refractory disease. In the context of relapsed or refractory DLBCL, glofitamab provides an alternative treatment option for patients having failed other systemic therapies or for whom targeted therapies - such as CAR-T cell therapy - are inappropriate. In June 2023, the FDA approved the use of glofitamab for the treatment of patients with relapsed or refractory DLBCL not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy under accelerated approval based on response rate and durability of response. Glofitamab was granted conditional marketing authorization in July 2023 by the EMA for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. This approval is based on the positive results obtained from the phase I/II NP30179 study, where 35.2% of study participants achieved a complete response.
Indication
Glofitamab is indicated in Canada for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from follicular lymphoma, or primary mediastinal B-cell lymphoma (PMBCL), who have received two or more lines of systemic therapy and are ineligible to receive or cannot receive CAR-T cell therapy or have previously received CAR-T cell therapy. This indication has been authorized pending the results of trials designed to verify glofitamab's clinical benefit. The FDA approved glofitamab under accelerated approval for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. Glofitamab was also approved by the EMA to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Associated Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Large B Cell Lymphoma
- Primary Mediastinal (Thymic) Large B Cell Lymphoma (PMBCL)
- Refractory Diffuse Large B Cell Lymphoma (DLBCL)
- Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
- Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
- Relapsed or Refractory Diffuse Large B Cell Lymphoma (DLBCL)
- Relapsed Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/10 | Phase 2 | Not yet recruiting | Shanghai Zhongshan Hospital | ||
2025/06/04 | Phase 2 | Not yet recruiting | |||
2025/05/30 | Phase 2 | Recruiting | |||
2025/05/29 | N/A | Not yet recruiting | The Lymphoma Academic Research Organisation | ||
2025/04/10 | Phase 1 | Not yet recruiting | City of Hope Medical Center | ||
2025/03/25 | Phase 2 | Recruiting | |||
2025/03/10 | Phase 2 | Not yet recruiting | Liling Zhang | ||
2025/02/03 | Phase 2 | Recruiting | |||
2024/11/01 | Phase 2 | Not yet recruiting | |||
2024/10/24 | N/A | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Genentech, Inc. | 50242-127 | INTRAVENOUS | 10 mg in 10 mL | 6/18/2025 | |
| Genentech, Inc. | 50242-125 | INTRAVENOUS | 2.5 mg in 2.5 mL | 6/18/2025 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/7/2023 | ||
Authorised | 7/7/2023 | ||
Authorised | 7/7/2023 | ||
Authorised | 7/7/2023 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| COLUMVI CONCENTRATE FOR SOLUTION FOR INFUSION 1MG/ML | SIN16968P | INFUSION, SOLUTION CONCENTRATE | 1 mg/ml | 3/5/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Glofitamab Injection | 国药准字SJ20230017 | 生物制品 | 注射剂 | 11/7/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| COLUMVI CONCENTRATE FOR SOLUTION FOR INFUSION 10MG/10ML | N/A | N/A | N/A | 12/8/2023 | |
| COLUMVI CONCENTRATE FOR SOLUTION FOR INFUSION 2.5MG/2.5ML | N/A | N/A | N/A | 12/8/2023 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| COLUMVI glofitamab (rch) 10 mg/10 mL concentrated solution for infusion vial | 392331 | Medicine | A | 8/9/2023 | |
| COLUMVI glofitamab (rch) 2.5 mg/2.5 mL concentrated solution for infusion vial | 389650 | Medicine | A | 8/9/2023 |