MedPath

Glofitamab

Generic Name
Glofitamab
Brand Names
Columvi
Drug Type
Biotech
CAS Number
2229047-91-8
Unique Ingredient Identifier
06P3KLK2J8

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.

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
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

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
No NMPA approvals found for this drug.

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

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
COLUMVI
Hoffmann-La Roche Limited
02536560
Solution - Intravenous
10 MG / 10 ML
7/5/2023
COLUMVI
Hoffmann-La Roche Limited
02536552
Solution - Intravenous
2.5 MG / 2.5 ML
7/5/2023

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
COLUMVI 2,5 MG CONCENTRADO PARA SOLUCION PARA PERFUSION
1231742001
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized
COLUMVI 10 MG CONCENTRADO PARA SOLUCION PARA PERFUSION
1231742002
CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN
Uso Hospitalario
Commercialized

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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