Drugs / Glofitamab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Columvi | — | 2023-07-07 | europa.eu ↗ |
Trials 77 · started per year
today
EU approved 2023
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04161248 | Sep 2020 → Dec 2026 expected | B-cell non-Hodgkin lymphoma | Canadian Cancer Trials Group | Active not recruiting | No outcome recorded |
| Phase 114 trials | ||||||
| Phase 1 | NCT07649304 | Sep 2026 → Apr 2028 expected | high grade B-cell lymphoma, high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement, plasmablastic lymphoma, primary effusion lymphoma | National Cancer Institute (NCI) | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07444710 | Aug 2026 → Sep 2027 expected | mantle cell lymphoma | National Cancer Institute (NCI) | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07528352 | Jun 2026 → Jun 2030 expected | diffuse large B-cell lymphoma | University of Utah | Recruiting | No outcome recorded |
| Phase 1 | NCT06922604 | Jul 2025 → Jan 2029 | central nervous system non-hodgkin lymphoma | City of Hope Medical Center | Suspended | No outcome recorded |
| Phase 1 | NCT06624085 | Apr 2025 → Mar 2030 expected | lymphoma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1 | NCT06192888 | Jan 2024 → Jan 2028 expected | mantle cell lymphoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05364424 | Nov 2022 → Oct 2025 | diffuse large B-cell lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT05169515 | Oct 2022 → Sep 2029 expected | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1 | NCT04970901 | Jun 2022 → Mar 2027 expected | B-cell non-Hodgkin lymphoma | ADC Therapeutics S.A. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05219513 | Feb 2022 → Jul 2024 | non-Hodgkin lymphoma | Hoffmann-La Roche | Terminated | No outcome recorded |
| Phase 1 | NCT04657302 | Jan 2021 → Oct 2022 | lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT04231877 | Oct 2020 → Dec 2026 expected | ALK-positive large B-cell lymphoma, B-cell lymphoma, unclassifiable, with features intermediate between diffuse large b-cell lymphoma and classical Hodgkin lymphoma, T-cell/histiocyte rich large B cell lymphoma, high grade B-cell lymphoma +2 | University of Washington | Recruiting | No outcome recorded |
| Phase 1 | NCT04313608 | Jun 2020 → Oct 2021 | B-cell neoplasm | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT03467373 | Mar 2018 → Dec 2024 | B-cell neoplasm, non-Hodgkin lymphoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1/210 trials | ||||||
| Phase 1/2 | NCT07643805 | Jun 2026 → Jan 2028 expected | diffuse large B-cell lymphoma | The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06357676 | May 2025 → Nov 2027 expected | mantle cell lymphoma | OHSU Knight Cancer Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06634589 | Nov 2024 → Dec 2028 expected | B-cell neoplasm | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06464185 | Apr 2024 → Mar 2026 overdue | B-cell non-Hodgkin lymphoma | Institute of Hematology & Blood Diseases Hospital, China | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06090539 | Dec 2023 → Oct 2027 expected | non-Hodgkin lymphoma | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05861050 | Aug 2023 → Feb 2027 expected | mantle cell lymphoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05533775 | Nov 2022 → Nov 2029 expected | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04914741 | Jun 2021 → Dec 2023 overdue | high grade B-cell lymphoma | Peter MacCallum Cancer Centre, Australia | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03533283 | May 2018 → Oct 2026 expected | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03075696 | Feb 2017 → Mar 2029 expected | non-Hodgkin lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 248 trials | ||||||
| Phase 2 | NCT07634289 | Dec 2026 → Dec 2031 expected | diffuse large B-cell lymphoma | Olivia Newton-John Cancer Research Institute | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07711483 | Oct 2026 → Oct 2028 expected | B-cell non-Hodgkin lymphoma, large B-cell lymphoma | Massachusetts General Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07702851 | Sep 2026 → Aug 2030 expected | diffuse large B-cell lymphoma | Yonsei University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07599423 | Jul 2026 → Jul 2030 expected | diffuse large B-cell lymphoma | The First Affiliated Hospital of Soochow University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07003295 | Jul 2026 → Aug 2027 expected | mantle cell lymphoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07453095 | Jun 2026 → Jul 2028 expected | mantle cell lymphoma | Fondazione Italiana Linfomi - ETS | Recruiting | No outcome recorded |
| Phase 2 | NCT07594899 | May 2026 → May 2029 expected | large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07502872 | May 2026 → Dec 2029 expected | high grade B-cell lymphoma | Brown University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07387848 | Apr 2026 → Dec 2031 expected | relapsed/refractory diffuse large B-cell lymphoma | American University of Beirut Medical Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07257055 | Apr 2026 → Nov 2028 expected | — | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07542678 | Apr 2026 → Apr 2028 expected | relapsed/refractory diffuse large B-cell lymphoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07514169 | Mar 2026 → Dec 2028 expected | large B-cell lymphoma | Ruijin Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07326371 | Mar 2026 → Jul 2027 expected | diffuse large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07231250 | Jan → Sep 2026 expected | diffuse large B-cell lymphoma | Li Zhiming | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07480850 | Jan 2026 → Jan 2028 expected | diffuse large B-cell lymphoma | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07184788 | Oct 2025 → Oct 2030 expected | aggressive B-cell non-Hodgkin lymphoma | Navy General Hospital, Beijing | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06665217 | Sep 2025 → Jan 2029 expected | diffuse large B-cell lymphoma | Navy General Hospital, Beijing | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07240194 | Sep 2025 → Dec 2028 expected | large B-cell lymphoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT07460362 | Aug 2025 → Dec 2027 expected | mantle cell lymphoma | Peking University Third Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06670105 | Jun 2025 → Jan 2030 | large B-cell lymphoma | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT07012980 | Jun 2025 → Jul 2026 overdue | diffuse large B-cell lymphoma | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06570447 | May 2025 → Dec 2026 expected | diffuse large B-cell lymphoma | Tianjin Medical University Cancer Institute and Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06996132 | May 2025 → May 2027 expected | aggressive B-cell non-Hodgkin lymphoma | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT06867536 | Apr 2025 → Aug 2028 expected | relapsed/refractory diffuse large B-cell lymphoma | Liling Zhang | Recruiting | No outcome recorded |
| Phase 2 | NCT06806033 | Mar 2025 → Jan 2027 expected | B-cell non-Hodgkin lymphoma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 2 | NCT06558604 | Feb 2025 → May 2028 expected | mantle cell lymphoma | The Lymphoma Academic Research Organisation | Recruiting | No outcome recorded |
| Phase 2 | NCT06050694 | Jan 2025 → Nov 2027 expected | diffuse large B-cell lymphoma | University Health Network, Toronto | Recruiting | No outcome recorded |
| Phase 2 | NCT06765317 | Jan 2025 → Jan 2028 expected | high grade B-cell lymphoma | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06534437 | Dec 2024 → Dec 2026 expected | aggressive B-cell non-Hodgkin lymphoma | Ryvu Therapeutics SA | Recruiting | No outcome recorded |
| Phase 2 | NCT06054776 | Dec 2024 → Oct 2026 expected | mantle cell lymphoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06656221 | Dec 2024 → Dec 2026 expected | mantle cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06552572 | Nov 2024 → Jun 2026 overdue | diffuse large B-cell lymphoma | Samsung Medical Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06682130 | Nov 2024 → Nov 2027 expected | diffuse large B-cell lymphoma | The First Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| Phase 2 | NCT06651853 | Oct 2024 → Dec 2027 expected | diffuse large B-cell lymphoma | The First Affiliated Hospital of Xiamen University | Recruiting | No outcome recorded |
| Phase 2 | NCT06567366 | Sep 2024 → Sep 2027 expected | large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06071871 | Aug 2024 → Jul 2027 expected | large B-cell lymphoma | University College, London | Recruiting | No outcome recorded |
| Phase 2 | NCT06252675 | Jun 2024 → Jul 2028 expected | mantle cell lymphoma | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 2 | NCT06213311 | May 2024 → Jul 2027 expected | large B-cell lymphoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06186648 | Mar 2024 → Mar 2028 expected | Richter transformation | French Innovative Leukemia Organisation | Recruiting | No outcome recorded |
| Phase 2 | NCT06043674 | Jan 2024 → Jan 2028 expected | B-cell chronic lymphocytic leukemia, Richter transformation | Christine Ryan | Recruiting | No outcome recorded |
| Phase 2 | NCT05833763 | Oct 2023 → Apr 2032 expected | mantle cell lymphoma | Australasian Leukaemia and Lymphoma Group | Recruiting | No outcome recorded |
| Phase 2 | NCT05783596 | Jul 2023 → Aug 2026 overdue | follicular lymphoma, marginal zone lymphoma | Reid Merryman, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05800366 | Apr 2023 → Sep 2026 expected | diffuse large B-cell lymphoma | Jennifer Crombie, MD | Recruiting | No outcome recorded |
| Phase 2 | NCT05798156 | Mar 2023 → Apr 2025 overdue | diffuse large B-cell lymphoma | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05335018 | May 2022 → Nov 2025 overdue | diffuse large B-cell lymphoma | Seoul National University Hospital | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04980222 | Mar 2022 → Sep 2026 expected | lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04889716 | Nov 2021 → Dec 2027 expected | diffuse large B-cell lymphoma, large B-cell lymphoma | Abramson Cancer Center at Penn Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT04703686 | Mar 2021 → Jan 2023 | indolent B-cell non-Hodgkin lymphoma, mantle cell lymphoma, primary mediastinal large B-cell lymphoma | The Lymphoma Academic Research Organisation | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06084936 | Oct 2023 → Aug 2027 expected | lymphoma | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT06047080 | Sep 2023 → Oct 2027 expected | large B-cell lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04408638 | Feb 2021 → Mar 2028 expected | diffuse large B-cell lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06956092 | May 2025 → Jun 2028 expected | large B-cell lymphoma | Zhengzhou University | Not yet recruiting | No outcome recorded |
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06393738 Background | Sep 2024 → Mar 2028 expected | B-cell non-Hodgkin lymphoma, angioimmunoblastic T-cell lymphoma | Arvinas Inc. | Recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05896163 Background | Aug 2023 → Apr 2026 | diffuse large B-cell lymphoma | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT04077723 Background | Aug 2019 → Mar 2027 expected | non-Hodgkin lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07602322 Comparator | May 2026 → May 2028 expected | large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07613788 Background | May 2026 → Nov 2028 expected | large B-cell lymphoma | Ruijin Hospital | Not yet recruiting | No outcome recorded |
Press releases naming this drug 16 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-12-08 | Roche Global Development | Roche’s Columvi combination shows sustained survival benefit at three-year follow up of pivotal phase III STARGLO study roche.com ↗ |
| 2025-05-23 | Roche Global Development | New two-year follow-up of Roche’s Columvi extends overall survival in relapsed or refractory diffuse large B-cell lymphoma patients roche.com ↗ |
| 2025-05-20 | Roche Global Development | Roche provides update on FDA Advisory Committee meeting on Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma roche.com ↗ |
| 2025-04-14 | Roche Global Development | European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy roche.com ↗ |
| 2025-02-28 | Roche Global Development | CHMP recommends EU approval of Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma roche.com ↗ |
| 2024-12-10 | Roche Global Development | New and updated data for Roche's fixed-duration Columvi and Lunsumio at ASH 2024 reinforce their potential to improve outcomes for people with lymphoma roche.com ↗ |
| 2024-12-05 | Roche Global Development | FDA accepts supplemental Biologics License Application for Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma roche.com ↗ |
| 2024-06-15 | Roche Global Development | Roche’s Phase III STARGLO study demonstrates Columvi significantly extends survival in people with relapsed or refractory diffuse large B-cell lymphoma roche.com ↗ |
| 2024-04-15 | Roche Global Development | [Ad hoc announcement pursuant to Art. 53 LR] Roche’s Columvi meets primary endpoint of overall survival in people with relapsed or refractory diffuse large B-cell lymphoma in Phase III STARGLO study roche.com ↗ |
| 2023-12-11 | Roche Global Development | New data for Roche’s Columvi and Lunsumio presented at ASH 2023 support continued benefit for people with lymphoma roche.com ↗ |
| 2023-07-11 | Roche Global Development | European Commission approves Roche’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma roche.com ↗ |
| 2023-06-16 | Roche Global Development | FDA approves Roche’s Columvi, the first and only bispecific antibody with a fixed-duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma roche.com ↗ |
| 2023-04-26 | Roche Global Development | CHMP recommends EU approval of Roche’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma roche.com ↗ |
| 2023-01-06 | Roche Global Development | FDA grants priority review to Roche’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma roche.com ↗ |
| 2022-05-27 | Roche Global Development | New pivotal data demonstrate clinical benefit of Roche’s glofitamab, a potential first-in-class bispecific antibody for people with aggressive lymphoma roche.com ↗ |
| 2022-05-27 | Roche Global Development | New pivotal data demonstrate clinical benefit of Roche’s glofitamab, a potential first-in-class bispecific antibody for people with aggressive lymphoma roche.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 85 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Glofitamab | “Participants will receive intravenous (IV) glofitamab in combination with gemcitabine and oxaliplatin for up to 8 cycles, followed by up to 4 cycles of glofitamab monotherapy.” NCT04313608 ↗80“Participants will receive IV glofitamab, both in combination with gemcitabine and oxaliplatin and as monotherapy, for up to 12 cycles (cycle length = 21 days).” NCT06806033 ↗ “Single-Arm Clinical Study of Zeprumetostat in Combination with Glofitamab + GemOx in Patients with Relapsed/ Refractory DLBCL” NCT07643805 ↗ “Glofitamab: 2.5 mg, C1D8; 10 mg,C1D15 ; 30 mg,C2D1 and C3D1, IV.” NCT06464185 ↗ “Glofitamab introvenous infusion Group A: 2.5mg day8” NCT06682130 ↗ |
| Known as | Columvi | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298092 ↗ |
| Known as | Glofit | “Participants will receive up to 8 cycles of glofitamab (Glofit) in combination with gemcitabine and oxaliplatin (GemOx), followed by up to 4 cycles of glofitamab monotherapy.” NCT04408638 ↗ |
| Known as | Glofitamab-gxbm | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298092 ↗ |
| Known as | RG-6026 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298092 ↗ |
| Known as | RO7082859 | “Glofitamab (RO7082859)” NCT06047080 ↗ |
| Action | Deplete | “Preclinical studies showed that glofitamab leads to T-cell activation, proliferation, and tumor cell killing upon binding to CD20 on malignant cells.” PMID 34941996 ↗ Feb 2022 |
| Modality | Monoclonal antibody | “Glofitamab is a bispecific antibody that recruits T cells to tumor cells.” PMID 36507690 ↗ Dec 2022 |
| Route | Intravenous | “glofitamab, administered by intravenous (IV) infusion” NCT03075696 ↗ |
| Target | MS4A1 | “B-lymphocyte antigen CD20 binding agent” CHEMBL4298092 ↗ |