{ "id": "epcsdp4m2k", "slug": "glofitamab", "title": "Glofitamab", "updated": "2026-10-15", "topic_path": [ { "id": "life", "label": "Life and health", "api_url": "https://www.edgepedia.org/api/v1/topics/life" }, { "id": "life.health", "label": "Human health and medicine", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health" }, { "id": "life.health.medicines", "label": "Medicines and therapeutics", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health.medicines" }, { "id": "life.health.medicines.biologics-mabs", "label": "Biologics, monoclonal antibodies, and biosimilars", "api_url": "https://www.edgepedia.org/api/v1/topics/life.health.medicines.biologics-mabs" } ], "geo": [ { "id": "geo.nongeo.t2001.life.health.medicines", "label": "Non-geographic · 2001 to 2020: Medicines and therapeutics", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health.medicines", "path": [ { "id": "geo.nongeo", "label": "Non-geographic", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo" }, { "id": "geo.nongeo.t2001", "label": "Non-geographic · 2001 to 2020", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001" }, { "id": "geo.nongeo.t2001.life", "label": "Life and health", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life" }, { "id": "geo.nongeo.t2001.life.health", "label": "Human health and medicine", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health" }, { "id": "geo.nongeo.t2001.life.health.medicines", "label": "Medicines and therapeutics", "api_url": "https://www.edgepedia.org/api/v1/geo/geo.nongeo.t2001.life.health.medicines" } ] } ], "excerpt": "Glofitamab, sold as Columvi, is a CD20×CD3 bispecific antibody that treats relapsed or refractory diffuse large B-cell lymphoma, approved in Europe and North America in 2023.", "snippet": "Glofitamab, sold as Columvi, is a CD20×CD3 bispecific antibody that treats relapsed or refractory diffuse large B-cell lymphoma, approved in Europe and North America in 2023.", "node": "life.health.medicines.biologics-mabs", "markdown": "# Glofitamab\n\nGlofitamab (Columvi; development codes RO7082859/RG6026) is a CD20-directed CD3 T-cell-engaging bispecific antibody used to treat relapsed or refractory B-cell lymphomas, given as monotherapy or in combination with obinutuzumab, polatuzumab vedotin, or gemcitabine and oxaliplatin.[1](https://pmc.ncbi.nlm.nih.gov/articles/PMC10245362/) It carries a 2:1 (2+1) head-to-tail configuration with two anti-CD20 binding arms and one anti-CD3 arm, and is approved in Europe and North America for eligible adult patients with relapsed or refractory diffuse large [B-cell lymphoma](https://www.edgepedia.org/b-cell-lymphoma) (DLBCL, NOS) or large B-cell lymphoma arising from follicular lymphoma after two or more prior lines of systemic therapy, whereas primary mediastinal B-cell lymphoma is included only in the Canadian indication.[2](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3516e753-f064-4d30-9bd5-e3f2e143f75d) [The Canadian](https://www.edgepedia.org/the-canadian) monograph restricts monotherapy to patients ineligible for or previously treated with [CAR T-cell therapy](https://www.edgepedia.org/car-t-cell-therapy), and extends the indication to glofitamab plus gemcitabine and oxaliplatin for DLBCL patients who are not candidates for autologous stem cell transplant.[3](https://assets.roche.com/f/173850/x/f54500f377/columvi_pm_e.pdf)\n\n| Key fact | Detail |\n|---|---|\n| Drug class | Full-length IgG1 CD20 × CD3 T-cell-engaging bispecific antibody, 2:1 (CD20:CD3) format[4](https://link.springer.com/article/10.1186/s13045-023-01488-4) |\n| Approved indications | R/R DLBCL NOS, LBCL arising from follicular lymphoma, and PMBCL after ≥2 lines; plus GemOx combination for R/R DLBCL not candidates for ASCT[2](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3516e753-f064-4d30-9bd5-e3f2e143f75d) • [3](https://assets.roche.com/f/173850/x/f54500f377/columvi_pm_e.pdf) |\n| Standard dosing | Obinutuzumab 1,000 mg on Cycle 1 Day 1, then glofitamab 2.5 mg (Day 8), 10 mg (Day 15), 30 mg on Day 1 of Cycles 2–12; 21-day cycles, fixed duration[2](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3516e753-f064-4d30-9bd5-e3f2e143f75d) |\n| Monotherapy efficacy (phase II) | Complete response 39%, overall response 52%, median PFS 4.9 months[1](https://pmc.ncbi.nlm.nih.gov/articles/PMC10245362/) |\n| Glofit-Pola combination | ORR 78.3%, CR 59.7%, median PFS 12.3 months, median OS 33.8 months[5](https://doi.org/10.1200/jco-25-00992) |\n| Key toxicities | CRS in 70% of pivotal-trial patients (grade ≥3: 4.1%), ICANS 4.8%, serious infections 16%, tumor flare 12%; Boxed Warning for serious or fatal CRS[6](https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-glofitamab-gxbm-selected-relapsed-or-refractory-large-b-cell) |\n| Half-life | 10 days, longer than earlier-generation bispecifics[4](https://link.springer.com/article/10.1186/s13045-023-01488-4) |\n\n## How it works\n\nGlofitamab is a full-length humanized IgG1 bispecific antibody with two Fab regions that bind CD20 on malignant B cells and one that binds CD3ε within the [T-cell receptor](https://www.edgepedia.org/t-cell-receptor) complex, in a 2:1 (CD20:CD3) format.[7](https://dctd.cancer.gov/drug-discovery-development/reagents-materials/formulary/about/agents/glofitamab) • [8](https://www.guidetopharmacology.org/GRAC/LigandDisplayForward?ligandId=12758&tab=refs) The bivalent CD20 binding gives high avidity on B cells, while the monovalent CD3 arm forms an immunological synapse between the lymphoma cell and the [T cell](https://www.edgepedia.org/t-cell), driving T-cell activation, cytokine secretion, and lysis of CD20-expressing B cells even at low effector-to-target ratios.[3](https://assets.roche.com/f/173850/x/f54500f377/columvi_pm_e.pdf) • [7](https://dctd.cancer.gov/drug-discovery-development/reagents-materials/formulary/about/agents/glofitamab) Killing is mediated by direct recruitment and activation of autologous T cells in the vicinity of lymphoma cells, with secretion of granzymes and perforins.[9](https://www.nature.com/articles/s41375-026-03003-3) The Fc region carries a PG LALA mutation that abolishes Fc-FcγR interaction while retaining FcRn binding, which reduces off-target Fc-mediated effector activity and gives a half-life of 10 days, longer than earlier-generation bispecifics.[4](https://link.springer.com/article/10.1186/s13045-023-01488-4)\n\n## How it is done\n\nTreatment follows a fixed schedule designed to mitigate cytokine release syndrome (CRS). All patients receive a single 1,000 mg dose of obinutuzumab, an anti-CD20 antibody, on Cycle 1 Day 1, seven days before glofitamab, to deplete circulating B cells and reduce the target burden that drives CRS.[3](https://assets.roche.com/f/173850/x/f54500f377/columvi_pm_e.pdf) Glofitamab then starts with step-up dosing: 2.5 mg on Day 8 and 10 mg on Day 15 of Cycle 1, followed by the recommended 30 mg dose on Day 1 of Cycles 2 through 12, each cycle lasting 21 days.[2](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3516e753-f064-4d30-9bd5-e3f2e143f75d) Monotherapy is given for a fixed duration of up to 12 cycles, or until disease progression or unmanageable toxicity.[3](https://assets.roche.com/f/173850/x/f54500f377/columvi_pm_e.pdf) At least one dose of tocilizumab, for use in the event of CRS, must be available before the Cycle 1 and Cycle 2 infusions, with access to an additional dose within 8 hours of the previous dose.[3](https://assets.roche.com/f/173850/x/f54500f377/columvi_pm_e.pdf) In the glofitamab plus polatuzumab vedotin trial, patients were hospitalized for 24 hours after the first glofitamab dose.[5](https://doi.org/10.1200/jco-25-00992)\n\n## Origin\n\nAs of July 2022, [Chugai Pharmaceutical](https://www.edgepedia.org/chugai-pharmaceutical) had in-licensed it for development and distribution in Japan.[1](https://pmc.ncbi.nlm.nih.gov/articles/PMC10245362/) The first-in-human study, NP30179 (ClinicalTrials.gov NCT03075696), was a phase I dose-escalation trial of single-agent glofitamab after single-dose obinutuzumab pretreatment.[10](https://ascopubs.org/doi/10.1200/JCO.20.03175) • [11](https://www.clinicaltrials.gov/ct2/show/NCT03075696) Glofitamab received approval, with conditions, on 25 March 2023 in Canada; on 26 April 2023 the EMA Committee for Medicinal Products for Human Use adopted a positive opinion recommending conditional marketing authorization in the EU; and the FDA granted accelerated approval on June 15, 2023, after Fast Track designation in January 2023.[1](https://pmc.ncbi.nlm.nih.gov/articles/PMC10245362/) • [6](https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-glofitamab-gxbm-selected-relapsed-or-refractory-large-b-cell) The FDA approval was based on NP30179, in which 132 efficacy-evaluable patients had received a median of 3 prior lines.[6](https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-glofitamab-gxbm-selected-relapsed-or-refractory-large-b-cell)\n\n## Variants\n\nTwo glofitamab-based combination regimens have been developed beyond monotherapy. The glofitamab plus polatuzumab vedotin regimen (Glofit-Pola) was reported by Martin Hutchings and colleagues in the Journal of Clinical Oncology in 2025, from the phase Ib/II trial NCT03533283.[5](https://doi.org/10.1200/jco-25-00992) Its dosing pairs obinutuzumab 1,000 mg on C1D1 with polatuzumab vedotin 1.8 mg/kg on C1D2 and Cycles 2–6, and glofitamab step-up 2.5 mg (D8) and 10 mg (D15) then 30 mg on Day 1 of Cycles 2–12.[5](https://doi.org/10.1200/jco-25-00992) The glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) regimen was evaluated against rituximab-GemOx in the STARGLO phase 3 trial, reported by Jeremy S Abramson and colleagues in [The Lancet](https://www.edgepedia.org/the-lancet) in 2024.[12](https://doi.org/10.1016/s0140-6736%2824%2901774-4) As of April 2025, the EMA label covers Columvi in combination with gemcitabine and oxaliplatin for adult patients with relapsed or refractory DLBCL.[13](https://ec.europa.eu/health/documents/community-register/2025/20250410165867/anx_165867_en.pdf) Other combinations under study include glofitamab with [loncastuximab tesirine](https://www.edgepedia.org/loncastuximab-tesirine) and glofitamab with polatuzumab vedotin plus R-CHP in untreated DLBCL.[5](https://doi.org/10.1200/jco-25-00992) • [4](https://link.springer.com/article/10.1186/s13045-023-01488-4)\n\n## Applications\n\nIn the phase I trial, the overall response rate was 53.8% (CR 36.8%) across all doses and 65.7% (CR 57.1%) at the recommended phase II dose; of 63 patients achieving CR, 53 (84.1%) had an ongoing CR with a maximum follow-up of 27.4 months.[10](https://ascopubs.org/doi/10.1200/JCO.20.03175) In the phase II part of NP30179 (n=155), at a median follow-up of 12.6 months, the complete response rate was 39% and the objective response rate 52% in the intent-to-treat population, with median PFS 4.9 months, median OS 11.5 months, and a median time to complete response of 42 days.[1](https://pmc.ncbi.nlm.nih.gov/articles/PMC10245362/) Updated follow-up showed CR 38% and ORR 59% at a median follow-up of 20.1 months, with median duration of CR 24.1 months.[4](https://link.springer.com/article/10.1186/s13045-023-01488-4) The Glofit-Pola combination, in 129 patients with R/R large B-cell lymphoma as of September 2, 2024, gave an independent-review ORR of 78.3% and CR rate of 59.7%, with median PFS 12.3 months and median OS 33.8 months.[5](https://doi.org/10.1200/jco-25-00992) In STARGLO, overall survival was significantly improved with Glofit-GemOx versus R-GemOx (hazard ratio 0.59, 95% CI 0.40–0.89; p=0.011) at the primary analysis; at an updated analysis with median follow-up 20.7 months, median OS was 25.5 months with Glofit-GemOx versus 12.9 months with R-GemOx (HR 0.62).[12](https://doi.org/10.1016/s0140-6736%2824%2901774-4)\n\n## Limitations and alternatives\n\nThe prescribing information carries a Boxed Warning for serious or fatal cytokine release syndrome.[6](https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-glofitamab-gxbm-selected-relapsed-or-refractory-large-b-cell) Among 145 safety-evaluated patients in the FDA review, CRS occurred in 70% (grade ≥3: 4.1%), immune effector cell-associated neurotoxicity syndrome (ICANS) in 4.8%, serious infections in 16%, and tumor flare in 12%.[6](https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-glofitamab-gxbm-selected-relapsed-or-refractory-large-b-cell) In the Glofit-Pola trial, CRS occurred in 43.4% of patients (grade 1–2: 41.9%; one grade 5 event), and grade 3–4 adverse events in 58.9%.[5](https://doi.org/10.1200/jco-25-00992) In STARGLO, CRS occurred in 76 (44%) of 172 glofitamab-exposed patients and was predominantly low grade.[12](https://doi.org/10.1016/s0140-6736%2824%2901774-4) [Management](https://www.edgepedia.org/management) centers on the step-up schedule, obinutuzumab pretreatment, and guaranteed tocilizumab availability before the first two glofitamab-containing cycles.[3](https://assets.roche.com/f/173850/x/f54500f377/columvi_pm_e.pdf)\n\nMonotherapy response rates in unselected real-world populations fall below trial figures: in a Korean multicenter cohort of 46 heavily pretreated patients, CRS occurred in 26.1%, all grade 1 or 2, with no ICANS or treatment-related deaths, while ORR was 39.1% and CR rate 32.6%.[14](https://link.springer.com/article/10.1007/s00277-026-07212-9) An interval of less than 1 month from prior therapy to glofitamab was associated with an ORR of 15.4% and median PFS of 1.0 month.[14](https://link.springer.com/article/10.1007/s00277-026-07212-9) Cross-trial comparators cited in the Glofit-Pola report include mosunetuzumab plus polatuzumab, polatuzumab-rituximab-bendamustine, and tafasitamab-lenalidomide.[5](https://doi.org/10.1200/jco-25-00992) Against CAR T-cell therapy, glofitamab-based regimens are positioned as fixed-duration, off-the-shelf, chemo-light options, since CAR-T safety profile, cost, and delivery time are significant barriers for many patients.[5](https://doi.org/10.1200/jco-25-00992) UK NHS guidance restricts glofitamab in patients who have received other CD20×CD3 bispecifics, allowing prior glofitamab monotherapy only as bridging for no more than 3 cycles.[15](https://www.kmcc.nhs.uk/s3/assets/haem-nhl-094-glofitamab-%28with-pre-treatment-obinutuzumab%29-v3.pdf)\n\n## References\n\n1. [Glofitamab: First Approval](https://pmc.ncbi.nlm.nih.gov/articles/PMC10245362/)\n2. [COLUMVI (glofitamab), DailyMed prescribing information](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3516e753-f064-4d30-9bd5-e3f2e143f75d)\n3. [COLUMVI Product Monograph (Roche Canada)](https://assets.roche.com/f/173850/x/f54500f377/columvi_pm_e.pdf)\n4. [CD20 × CD3 bispecific antibodies for lymphoma therapy: latest updates from ASCO 2023 annual meeting](https://link.springer.com/article/10.1186/s13045-023-01488-4)\n5. [Martin Hutchings and colleagues (2025). Efficacy and Safety of Glofitamab Plus Polatuzumab Vedotin in Relapsed/Refractory Large B-Cell Lymphoma Including High-Grade B-Cell Lymphoma: Results From a Phase Ib/II Trial. Journal of Clinical Oncology.](https://doi.org/10.1200/jco-25-00992)\n6. [FDA grants accelerated approval to glofitamab-gxbm for selected relapsed or refractory large B-cell lymphomas](https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-glofitamab-gxbm-selected-relapsed-or-refractory-large-b-cell)\n7. [Glofitamab-gxbm, NCI Drug Formulary](https://dctd.cancer.gov/drug-discovery-development/reagents-materials/formulary/about/agents/glofitamab)\n8. [glofitamab | IUPHAR/BPS Guide to PHARMACOLOGY](https://www.guidetopharmacology.org/GRAC/LigandDisplayForward?ligandId=12758&tab=refs)\n9. [Feasibility and safety of rapid glofitamab ramp-up (Leukemia)](https://www.nature.com/articles/s41375-026-03003-3)\n10. [Glofitamab, a Novel, Bivalent CD20-Targeting T-Cell–Engaging Bispecific Antibody, Induces Durable Complete Remissions in Relapsed or Refractory B-Cell Lymphoma: A Phase I Trial](https://ascopubs.org/doi/10.1200/JCO.20.03175)\n11. [A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab (NCT03075696)](https://www.clinicaltrials.gov/ct2/show/NCT03075696)\n12. [Glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab-GemOx for relapsed or refractory diffuse large B-cell lymphoma (STARGLO): a global phase 3, randomised, open-label trial (The Lancet, 2024)](https://doi.org/10.1016/s0140-6736%2824%2901774-4)\n13. [Columvi, INN-glofitamab, EMA annex (April 2025)](https://ec.europa.eu/health/documents/community-register/2025/20250410165867/anx_165867_en.pdf)\n14. [Real-world outcomes of glofitamab monotherapy in heavily pretreated patients with relapsed/refractory diffuse large B-cell lymphoma: A multicenter Korean cohort (Annals of Hematology)](https://link.springer.com/article/10.1007/s00277-026-07212-9)\n15. [haem nhl 094 glofitamab (with pre treatment obinutuzumab) v3 (kmcc.nhs.uk)](https://www.kmcc.nhs.uk/s3/assets/haem-nhl-094-glofitamab-%28with-pre-treatment-obinutuzumab%29-v3.pdf)\n\n---\n*Topic: Encyclopedia › Life and health › Human health and medicine › Medicines and therapeutics › Biologics, monoclonal antibodies, and biosimilars*\n\n*Initially written Sep 29, 2026 · Edited: Oct 15, 2026*\n\n*Copyright 2026 EdgeChat AI, a subsidiary of Biostate AI.*\n\nLicense: Edgepedia Community License 1.0, https://www.edgepedia.org/edgepedia/license\n", "same_as": [], "url": "https://www.edgepedia.org/glofitamab", "markdown_url": "https://www.edgepedia.org/glofitamab.md", "license": { "name": "Edgepedia Community License 1.0", "url": "https://www.edgepedia.org/edgepedia/license", "summary": "Free with credit, commercial use included. AI training is open to everyone. For other uses, organizations over USD 100M in revenue or 100M monthly users license separately.", "spdx": "LicenseRef-Edgepedia-Community-1.0" }, "credit": "\"Glofitamab\", Edgepedia (EdgeChat), https://www.edgepedia.org/glofitamab. Edgepedia Community License 1.0.", "credit_md": "\"[Glofitamab](https://www.edgepedia.org/glofitamab)\", Edgepedia (EdgeChat), [https://www.edgepedia.org/glofitamab](https://www.edgepedia.org/glofitamab). [Edgepedia Community License 1.0](https://www.edgepedia.org/edgepedia/license).", "credit_html": "\"Glofitamab\", Edgepedia (EdgeChat), https://www.edgepedia.org/glofitamab. Edgepedia Community License 1.0.", "speakable": "Glofitamab, sold as Columvi, is a CD20×CD3 bispecific antibody that treats relapsed or refractory diffuse large B-cell lymphoma, approved in Europe and North America in 2023." }