What is Glofitamab (anti-CD20 monoclonal antibody)?

From the FDA Drug Label

Based on its mechanism of action COLUMVI may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12. 1)]. There are no available data on the use of COLUMVI in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with glofitamab-gxbm. Glofitamab-gxbm causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance In addition, based on expression of CD20 on B cells and the finding of B-cell depletion in non-pregnant animals, glofitamab-gxbm can cause B-cell lymphocytopenia in infants exposed to glofitamab-gxbm in-utero. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, COLUMVI has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. In the U. S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Glofitamab may cause fetal harm when administered to a pregnant woman.

• There are no available data on the use of Glofitamab in pregnant women to evaluate for a drug-associated risk.
• Glofitamab has the potential to be transmitted from the mother to the developing fetus.
• The estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively 1. Key points:
• Glofitamab may cause fetal harm
• No data available for use in pregnant women
• Potential for transmission to fetus
• Background risk of major birth defects and miscarriage: 2% to 4% and 15% to 20%, respectively.

From the Research

Glofitamab is a recommended treatment option for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults who have received at least two prior lines of therapy, with a manageable safety profile and promising efficacy, as demonstrated in the most recent study published in 2025 2.

Key Points

• Glofitamab works by binding to both CD20 on B cells and CD3 on T cells, bringing them together to activate T cells to kill the cancerous B cells.
• The typical treatment regimen involves step-up dosing to reduce the risk of cytokine release syndrome (CRS): 2.5 mg on day 1,10 mg on day 8, and 30 mg on day 15 of cycle 1, followed by 30 mg every 3 weeks for cycles 2-12.
• Treatment is administered intravenously and is typically given for approximately one year (12 cycles).
• Patients should receive premedication with corticosteroids, acetaminophen, and antihistamines before each dose to minimize infusion reactions.
• Common side effects include CRS, neutropenia, fever, and headache.
• Patients require close monitoring, especially during the first doses, as CRS typically occurs within 24 hours of administration.
• Prophylactic treatment with tumor lysis syndrome prevention measures is also recommended for high-risk patients.

Efficacy and Safety

• The most recent study published in 2025 2 demonstrated a median overall survival of 14.7 months and a best overall metabolic response rate of 76.1% in patients with relapsed or refractory DLBCL after failing CAR-T cell therapy.
• The study also showed a favorable safety profile, with no excess cytokine release syndrome or neurotoxicity events observed.
• Another study published in 2024 3 reported an overall response rate of 47% and a median progression-free survival of 3.6 months in patients with relapsed or refractory DLBCL treated with glofitamab.

Real-World Data

• A real-world study published in 2023 4 reported a median overall survival of 8.8 months and a median progression-free survival of 3.3 months in patients with relapsed or refractory DLBCL treated with glofitamab.
• The study also highlighted the importance of close monitoring and management of toxicities, including hematological toxicity and cytokine release syndrome.

Special Considerations

• Glofitamab may be considered as salvage therapy for transformed relapsed/refractory DLBCL/HGBL-MYC/BCL2, as demonstrated in a case report published in 2025 5.
• Patients pretreated with bendamustine within 6 months prior to glofitamab initiation may exhibit reduced efficacy, as suggested by a study published in 2024 3.