Drugs / Glofitamab
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed diffuse large B-cell lymphoma 3 milestones | |||||
| Rejected (CRL) | US (FDA) | Columvi | diffuse large B-cell lymphoma | 2025-07-18 | “FDA issued a Complete Response Letter (CRL) for Genentech’s supplemental Biologics License Application (sBLA) for Columvi® (glofitamab-gxbm)” gene.com ↗ |
| Filed | US (FDA) | Columvi | diffuse large B-cell lymphoma | 2024-12-04 | “the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Columvi® (glofitamab-gxbm)” gene.com ↗ “the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Columvi® (glofitamab)” gene.com ↗ |
| Filed | EU (EMA) | — | diffuse large B-cell lymphoma | 2022-05-26 | “Roche submitted glofitamab for approval to the European Medicines Agency.” roche.com ↗ |
| Filed large B-cell lymphoma 1 milestone | |||||
| Filed | US (FDA) | — | large B-cell lymphoma | 2023-01-05 | “the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for glofitamab” gene.com ↗ “the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted priority review for glofitamab” gene.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Columvi | — | 2023-07-07 | europa.eu ↗ |
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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 113 trials | ||||||
| Phase 1 | NCT07444710 | Oct 2026 → Sep 2027 expected | mantle cell lymphoma | National Cancer Institute (NCI) | Not yet recruiting | No outcome recorded |
| 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 | 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 2027 expected | lymphoma | Hoffmann-La Roche | Active not 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 Stop: Business |
| Phase 1 | NCT04657302 | Jan 2021 → Oct 2022 | lymphoma | Hoffmann-La Roche | Completed | 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 1/211 trials · 1 met primary | ||||||
| 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 non-Hodgkin lymphoma | 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 | mantle cell lymphoma | City of Hope Medical Center | Suspended | 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 | NCT04231877 | Oct 2020 → Sep 2026 overdue | ALK-positive large B-cell lymphoma, T-cell/histiocyte rich large B cell lymphoma, high grade B-cell lymphoma, high grade B-cell lymphoma with MYC and/ or BCL2 and/or BCL6 rearrangement +1 | University of Washington | Active not recruiting | Met primary |
| 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 | NCT07502872 | Nov 2026 → Jan 2030 expected | high grade B-cell lymphoma | Brown University | 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 | 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 overdue | 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 | aggressive 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 → May 2026 overdue | follicular lymphoma, marginal zone lymphoma | Reid Merryman, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05800366 | Apr 2023 → Sep 2026 overdue | 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 → Oct 2024 overdue | 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 | Active not 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 34 trials · 1 met primary | ||||||
| Phase 3 | NCT07808827 | Sep 2026 → Nov 2028 expected | diffuse large B-cell lymphoma | Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting | No outcome recorded |
| 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 | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT06956092 | May 2025 → Jun 2028 expected | large B-cell lymphoma | Zhengzhou University | Not yet recruiting | No outcome recorded |
| Comparator or background therapy5 trials | ||||||
| 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 1/2 | NCT05896163 Background | Aug 2023 → Apr 2026 | diffuse large B-cell lymphoma | Pfizer | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04077723 Background | Aug 2019 → Mar 2027 expected | non-Hodgkin lymphoma | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| 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 |
News releases announcing trial results or a regulatory action · 52
| Date | Issuer | Release |
|---|---|---|
| 2025-12-08 | Hoffmann-La Roche | Results Roche’s Columvi combination shows sustained survival benefit at three-year follow up of pivotal phase III STARGLO study roche.com ↗
Overall survival was twice as long for people treated with Columvi in combination with GemOx versus MabThera/Rituxan plus GemOx1 |
| 2025-12-03 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Updated Data from LOTIS-7 Phase 1b Clinical Trial of ZYNLONTA® in Combination with Bispecific Antibody Supporting Potential Best-in-Class Regimen in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma adctherapeutics.com ↗
ZYNLONTA® in combination with glofitamab (COLUMVI®) demonstrated an 89.8% ORR and 77.6% CR across the 49 efficacy-evaluable patients with a minimum of 6 months of follow-up |
| 2025-12-01 | Bristol-Myers Squibb | Results Bristol Myers Squibb Data at ASH 2025 Showcase Potential of Hematology Pipeline and Build Momentum for Next Generation Portfolio bms.com ↗
Mosunetuzumab (mosun) or glofitamab (glofit) in combination with golcadomide (Golca) demonstrated a manageable safety profile and encouraging efficacy in patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (B-NHL) (partner study) |
| 2025-11-03 | Hoffmann-La Roche | Results Roche to present new data from its broad and innovative haematology portfolio at ASH 2025 roche.com ↗
Three-year follow-up and subgroup analyses from the phase III STARGLO study show continued superior survival outcomes with Columvi in combination with gemcitabine and oxaliplatin (GemOx) for people with R/R diffuse large B-cell lymphoma (DLBCL) |
| 2025-11-03 | Genentech, Inc. | Results Genentech to Present New Data From Its Broad and Innovative Hematology Portfolio at ASH 2025 gene.com ↗
Three-year follow-up and subgroup analyses from the Phase III STARGLO study show continued superior survival outcomes with Columvi in combination with gemcitabine and oxaliplatin (GemOx) for people with R/R diffuse large B-cell lymphoma (DLBCL) compared with Rituxan® (rituximab) and GemOx, including people with second-line DLBCL and primary refractory disease or early relapse.* |
| 2025-08-12 | ADC Therapeutics S.A. | Results ADC Therapeutics Reports Second Quarter 2025 Financial Results and Provides Operational Update adctherapeutics.com ↗
ZYNLONTA® in combination with glofitamab (COLUMVI®) demonstrated overall response rate (ORR) of 93.3% and a complete response (CR) rate of 86.7% in LOTIS-7 across 30 efficacy evaluable patients |
| 2025-07-18 | Genentech, Inc. | Regulatory Genentech Provides Update on Supplemental Biologics License Application for Columvi Combination for People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for Genentech’s supplemental Biologics License Application (sBLA) for Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant. |
| 2025-06-12 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Updated Data from LOTIS-7 Clinical Trial Presented at the European Hematology Association 2025 Congress adctherapeutics.com ↗
ZYNLONTA ® in combination with glofitamab (COLUMVI ® ) in patients with r/r DLBCL demonstrated clinically meaningful benefit with overall response rate (ORR) of 93.3% and a complete response (CR) rate of 86.7% across 30 efficacy evaluable patients |
| 2025-05-23 | Hoffmann-La Roche | Results New two-year follow-up of Roche’s Columvi extends overall survival in relapsed or refractory diffuse large B-cell lymphoma patients roche.com ↗
Updated data from the pivotal phase III STARGLO study continue to demonstrate a clinically meaningful improvement in overall survival with a 40% survival benefit for people with R/R DLBCL who are not candidates for transplant |
| 2025-05-22 | Genentech, Inc. | Results New Two-Year Follow-Up of Genentech’s Columvi Extends Overall Survival in Relapsed or Refractory Diffuse Large B-Cell Lymphoma Patients gene.com ↗
After a median follow-up of 24.7 months, data showed a 40% improvement in overall survival (OS) for patients treated with Columvi® (glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) and median OS was not reached, compared to 13.5 months for Rituxan® (rituximab) plus GemOx (R-GemOx). |
| 2025-05-20 | Hoffmann-La Roche | Regulatory Roche provides update on FDA Advisory Committee meeting on Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma roche.com ↗ |
| 2025-05-20 | Genentech, Inc. | Regulatory Genentech Provides Update on FDA Advisory Committee Meeting on Columvi Combination For People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma gene.com ↗
Genentech Provides Update on FDA Advisory Committee Meeting on Columvi Combination For People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| 2025-05-14 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Presentation of LOTIS-7 Clinical Trial Data at the European Hematology Association 2025 Congress (EHA2025) and the 18th International Conference on Malignant Lymphoma (ICML) adctherapeutics.com ↗
ZYNLONTA ® plus glofitamab (COLUMVI ® ) demonstrated ORR of 95.5% and CR of 90.9%, among 22 evaluable patients with relapsed/refractory DLBCL |
| 2025-04-14 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s Columvi as the first bispecific antibody for diffuse large B-cell lymphoma after initial therapy roche.com ↗
With this approval, this Columvi combination is the first bispecific antibody regimen available for people with DLBCL in Europe whose cancer has returned or for those who did not respond to initial treatment. |
| 2025-02-28 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma roche.com ↗ |
| 2024-12-11 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Positive Initial Data from LOTIS-7 Clinical Trial Evaluating ZYNLONTA® in Combination with Bispecific Antibody in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma adctherapeutics.com ↗
ZYNLONTA in combination with glofitamab demonstrated clinically meaningful benefit with 94% best ORR and 72% CR rate |
| 2024-12-10 | Hoffmann-La Roche | Results 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 ↗
Updated data from the phase I/Ib investigational NP39488 study showed high and durable response rates in people with R/R LBCL treated with Columvi in combination with Polivy, including those with high-grade disease and prior treatment with CAR T-cell therapy. |
| 2024-12-09 | Genentech, Inc. | Results New and Updated Data for Genentech’s Fixed-Duration Columvi and Lunsumio at ASH 2024 Reinforce Their Potential to Improve Outcomes for People With Lymphoma gene.com ↗
Updated data from the Phase I/Ib investigational NP39488 study showed high and durable response rates in people with R/R LBCL treated with Columvi in combination with Polivy, including those with high-grade disease and prior treatment with CAR T-cell therapy. |
| 2024-12-05 | Hoffmann-La Roche | Regulatory FDA accepts supplemental Biologics License Application for Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma roche.com ↗ |
| 2024-12-04 | Genentech, Inc. | Regulatory FDA Accepts Supplemental Biologics License Application for Genentech’s Columvi Combination for People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma gene.com ↗
FDA Accepts Supplemental Biologics License Application for Genentech’s Columvi Combination for People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| 2024-11-05 | Hoffmann-La Roche | Results Roche to present new and encouraging long-term follow-up data across broad haematology portfolio at ASH 2024 roche.com ↗
show long-lasting remissions and immune system recovery after the end of treatment |
| 2024-11-05 | Genentech, Inc. | Results Genentech to Present New and Encouraging Long-term Follow-up Data Across Broad Hematology Portfolio at ASH 2024 gene.com ↗
show long-lasting remissions and immune system recovery after the end of treatment |
| 2024-06-15 | Hoffmann-La Roche | Results Roche’s Phase III STARGLO study demonstrates Columvi significantly extends survival in people with relapsed or refractory diffuse large B-cell lymphoma roche.com ↗
The study met its primary endpoint of overall survival with a 41% reduction in the risk of death in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treated with Columvi plus chemotherapy1 |
| 2024-06-15 | Genentech, Inc. | Results Genentech’s Phase III STARGLO Study Demonstrates Columvi Significantly Extends Survival in People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma gene.com ↗
The study met its primary endpoint of overall survival with a 41% reduction in the risk of death in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treated with Columvi plus chemotherapy |
| 2024-04-15 | Hoffmann-La Roche | Results [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 ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Phase III STARGLO study met its primary endpoint of overall survival. |
| 2024-04-14 | Genentech, Inc. | Results Genentech’s Columvi Meets Primary Endpoint of Overall Survival in People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Phase III STARGLO Study gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the Phase III STARGLO study met its primary endpoint of overall survival. |
| 2024-04-04 | ADC Therapeutics S.A. | Results ADC Therapeutics Announces Updates on LOTIS-7 Clinical Trial Evaluating ZYNLONTA® in Combination with Glofitamab or Mosunetuzumab in Patients with Relapsed/Refractory B-cell Non-Hodgkin Lymphoma adctherapeutics.com ↗
Additionally, after the first investigator assessment, evidence of anti-tumor activity was observed among the majority of patients, with mixed histologies including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and marginal zone lymphoma (MZL). |
| 2024-01-04 | ADC Therapeutics S.A. | Results ADC Therapeutics Provides Business Updates adctherapeutics.com ↗
We are also encouraged to see positive initial signals in the LOTIS-7 trial of ZYNLONTA in combination with bispecifics as well as early signs of antitumor activity in the Phase 1b trial of ADCT-601. |
| 2023-12-11 | Hoffmann-La Roche | Results New data for Roche’s Columvi and Lunsumio presented at ASH 2023 support continued benefit for people with lymphoma roche.com ↗
Based on 32-month and 3-year follow-ups of two pivotal studies for fixed-duration treatments of Columvi® (glofitamab) and Lunsumio® (mosunetuzumab), respectively, data show that remissions were maintained in the majority of patients with heavily pre-treated lymphomas. |
| 2023-12-10 | Genentech, Inc. | Results New Data for Genentech’s Columvi and Lunsumio Presented at ASH 2023 Support Continued Benefit for People With Lymphoma gene.com ↗
Based on 32-month and 3-year follow-ups of two pivotal studies for fixed-duration treatments of Columvi® (glofitamab-gxbm) and Lunsumio® (mosunetuzumab-axgb), respectively, data show that remissions were maintained in the majority of patients with heavily pre-treated lymphomas. |
| 2023-07-11 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s fixed-duration Columvi (glofitamab) for people with relapsed or refractory diffuse large B-cell lymphoma roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has granted conditional marketing authorisation for Columvi® (glofitamab) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. |
| 2023-06-16 | Hoffmann-La Roche | Regulatory 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 ↗
This indication is approved under accelerated approval based on response rate and durability of response in the phase I/II NP30179 study. |
| 2023-06-15 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Columvi, the First and Only Bispecific Antibody With a Fixed-Duration Treatment for People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Columvi® (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. |
| 2023-04-26 | Hoffmann-La Roche | Regulatory 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 | Hoffmann-La Roche | Regulatory FDA grants priority review to Roche’s bispecific antibody glofitamab for people with relapsed or refractory large B-cell lymphoma roche.com ↗ |
| 2023-01-05 | Genentech, Inc. | Regulatory FDA Grants Priority Review to Genentech’s Bispecific Antibody Glofitamab for People With Relapsed or Refractory Large B-Cell Lymphoma gene.com ↗
FDA Grants Priority Review to Genentech’s Bispecific Antibody Glofitamab for People With Relapsed or Refractory Large B-Cell Lymphoma |
| 2022-12-12 | Hoffmann-La Roche | Results Roche presents new data demonstrating the potential benefit of glofitamab and Lunsumio as fixed-duration, off-the-shelf treatment options for lymphoma roche.com ↗
Data presented at ASH 2022 and simultaneously published in the New England Journal of Medicine showed that glofitamab, given as a fixed course, induced early and durable responses in people with heavily pre-treated large B-cell lymphoma1,2 |
| 2022-12-12 | Genentech, Inc. | Results Genentech Presents New Data Demonstrating the Potential of Glofitamab and Mosunetuzumab as Fixed-Duration, Off-The-Shelf Treatment Options for Lymphoma gene.com ↗
Data presented at ASH 2022 and simultaneously published in the New England Journal of Medicine showed that glofitamab, given as a fixed course, induced early and durable responses in people with heavily pretreated large B-cell lymphoma |
| 2022-11-03 | Hoffmann-La Roche | Results Roche to present data at ASH 2022 showcasing strength of haematology portfolio and expanding into new areas to address more patient needs roche.com ↗
New and updated data for innovative CD20xCD3 T-cell engaging bispecific antibodies Lunsumio and glofitamab further enhance their potential as effective, off-the-shelf, fixed-duration treatment options for people with lymphoma3,4,5,6,7 |
| 2022-11-03 | Genentech, Inc. | Results Genentech to Present Data at ASH 2022 Showcasing Strength of Hematology Portfolio and Expanding Into New Areas to Address More Patient Needs gene.com ↗
New and updated data for innovative CD20xCD3 T-cell engaging bispecific antibodies mosunetuzumab and glofitamab further enhance their potential as effective, off-the-shelf, fixed-duration treatment options for people with lymphoma |
| 2022-05-27 | Hoffmann-La Roche | Results New pivotal data demonstrate clinical benefit of Roche’s glofitamab, a potential first-in-class bispecific antibody for people with aggressive lymphoma roche.com ↗
Data from the phase II NP30179 expansion study demonstrated that, after a median follow-up of more than 12 months, fixed-duration glofitamab (given for a fixed amount of time, and not taken until disease progression) induces durable complete responses (CRs) in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who had received a median of three prior therapies. |
| 2022-05-27 | Hoffmann-La Roche | Results New pivotal data demonstrate clinical benefit of Roche’s glofitamab, a potential first-in-class bispecific antibody for people with aggressive lymphoma roche.com ↗
Data to be presented for the first time at ASCO and EHA 2022 show glofitamab induces high and durable complete response rates in people with heavily pre-treated diffuse large B-cell lymphoma¹ |
| 2022-05-26 | Genentech, Inc. | Results New Pivotal Data Demonstrate Clinical Benefit of Genentech’s Glofitamab, a Potential First-in-Class Bispecific Antibody for People with Aggressive Lymphoma gene.com ↗
New Pivotal Data Demonstrate Clinical Benefit of Genentech’s Glofitamab, a Potential First-in-Class Bispecific Antibody for People with Aggressive Lymphoma |
| 2021-12-11 | Hoffmann-La Roche | Results Roche presents pivotal data at ASH 2021 for novel cancer immunotherapy mosunetuzumab roche.com ↗
A phase I/Ib NP30179 dose-escalation study evaluating glofitamab as a monotherapy and in combination with Gazyva®/Gazyvaro® (obinutuzumab) following pretreatment with Gazyva/Gazyvaro in patients with R/R B-cell NHL showed promising activity in both R/R FL and R/R mantle cell lymphoma (MCL), an uncommon but aggressive form of lymphoma with poor prognosis for those who progress. |
| 2021-12-11 | Genentech, Inc. | Results Genentech Presents Pivotal Data at ASH 2021 for Novel Cancer Immunotherapy Mosunetuzumab gene.com ↗
Preliminary results in heavily pretreated patients with R/R FL showed high response rates across all treatment groups, including high-risk subgroups, with an ORR of 81.0% for the glofitamab monotherapy group and an ORR of 100% for the glofitamab plus Gazyva |
| 2021-11-23 | Hoffmann-La Roche | Results Roche to present new pivotal data at ASH 2021 from broad and comprehensive portfolio, challenging treatment standards for people with blood disorders roche.com ↗
Glofitamab As Monotherapy and in Combination with Obinutuzumab Induces High Complete Response Rates in Patients (pts) with Multiple Relapsed or Refractory (R/R) Follicular Lymphoma (FL)#128 oral presentation |
| 2021-11-23 | Genentech, Inc. | Results Genentech to Present New Pivotal Data at ASH 2021 From Broad and Comprehensive Portfolio, Challenging Treatment Standards for People With Blood Disorders gene.com ↗
Glofitamab As Monotherapy and in Combination with Obinutuzumab Induces High Complete Response Rates in Patients (pts) with Multiple Relapsed or Refractory (R/R) Follicular Lymphoma (FL) |
| 2021-06-04 | Hoffmann-La Roche | Results Roche presents latest advances with immunotherapies in non-Hodgkin lymphoma roche.com ↗
Data for investigational CD20xCD3 bispecific antibodies and new combination regimens with Polivy showed enhanced clinical benefits for people with non-Hodgkin lymphoma in early studies |
| 2021-06-04 | Genentech, Inc. | Results Genentech Presents Latest Advances With Immunotherapies in Non-Hodgkin’s Lymphoma gene.com ↗
Data for investigational CD20xCD3 bispecific antibodies and new combination regimens with Polivy showed enhanced clinical benefits for people with non-Hodgkin’s lymphoma in early studies |
| 2020-12-08 | Hoffmann-La Roche | Results Roche presents new data from its bispecific antibody portfolio across a range of blood cancers roche.com ↗ |
| 2020-11-05 | Hoffmann-La Roche | Results Roche to present new data across 16 blood disorders at the American Society of Hematology 2020 Annual Meeting roche.com ↗
Additionally, data demonstrating high response rates with step-up dosing of glofitamab in people with R/R NHL will be presented. |
| 2020-11-05 | Genentech, Inc. | Results Genentech to Present New Data Across 16 Blood Disorders at the American Society of Hematology 2020 Annual Meeting gene.com ↗
Additionally, data demonstrating high response rates with step-up dosing of glofitamab in people with R/R NHL will be presented. |
All press releases naming this drug 53 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 86 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Glofitamab | “This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (JS203-GemOx) compared with rituximab in combination with...” NCT07808827 ↗81“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 ↗ “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 ↗ |