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Glofitamab is a fixed-duration bispecific for large B-cell lymphoma, with OS benefit when combined with chemotherapy.
Glofitamab is a CD20×CD3 bispecific T-cell engager in a 2:1 format, with two CD20-binding arms and one CD3 arm, that recruits any passing T cell to kill a B cell. A single 1,000 mg dose of obinutuzumab is given first to blunt cytokine release, followed by step-up doses of 2.5 mg and 10 mg, then 30 mg every 3 weeks for up to 12 cycles, so treatment is fixed in duration. Accelerated US approval in 2023 and conditional EU authorisation followed a response rate of 56 percent with complete responses in 43 percent in relapsed or refractory DLBCL after two or more lines. STARGLO then showed an overall survival benefit when glofitamab was added to GemOx in transplant-ineligible relapsed DLBCL; the combination is approved in the EU and elsewhere, but the FDA declined in 2025 citing regional heterogeneity. Cytokine release syndrome, neutropenia and infections are the main toxicities.
Backbone ribbon from PDB 1IGT. RCSB PDB 1IGT. The ribbon widens where the chain is folded into a regular pattern and narrows where it is a loose loop.
No public structure of glofitamab; representative IgG shown.
1.One arm binds CD20 (bivalent, 2:1 format) on the tumour cell
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Step-up dosing is often started in hospital (Part A) because of cytokine release syndrome monitoring, then continued in the outpatient setting.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA927 · SMC advice: glofitamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy
Accelerated approval, relapsed/refractory DLBCL after ≥2 lines The confirmatory requirement was still open 3.3 years later, when the FDA's table was read. source
Conditional marketing authorisation source
Complete response letter for STARGLO combination (regional heterogeneity); approved in EU source
| Region | Year | Indication |
|---|---|---|
| US | 2023 | Relapsed/refractory DLBCL after ≥2 lines (accelerated) |
| Adverse event |
|---|
| Cytokine release syndrome |
| Neutropenia |
| Musculoskeletal pain |
| Rash |
| Fatigue |
| Infections |
| Tumour flare |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Read for the class this product belongs to (bispecific t-cell engagers) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | genentech-access.com |
| United Kingdom | NICE: recommended for relapsed/refractory DLBCL after ≥2 therapies (TA927) | not disclosed | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Glofitamab" OR ABSTRACT:"Glofitamab" OR TITLE:"Columvi" OR ABSTRACT:"Columvi") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Glofitamab, not a curated reading list.
Shares A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas, Head-to-head bispecific vs CAR-T in second-line LBCL, Hepatitis B reactivation before rituximab and other anti-CD20 antibodies, Step-up dosing (T-cell engagers).
Shares Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma, A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies, A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treat, A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combi.
Shares A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies, A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas, Hepatitis B reactivation before rituximab and other anti-CD20 antibodies, CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one.
Shares A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treat, A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combi, A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma, An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma.
Shares Head-to-head bispecific vs CAR-T in second-line LBCL, Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment, LYSA (The Lymphoma Study Association), Cytokine release syndrome and ICANS: grading and management.
Shares CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one, EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, Cytokine release syndrome and ICANS: grading and management, CD3.
Shares Hepatitis B reactivation before rituximab and other anti-CD20 antibodies, CD20 expression (CD20-positive), Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment, Cytokine release syndrome and ICANS: grading and management.
Shares Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment, Cytokine release syndrome and ICANS: grading and management, What the NHS in England funds for lymphoma, appraisal by appraisal, Primary mediastinal (thymic) large B-cell lymphoma.