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Drug

Glofitamab

Approved medicine
ClassB-lymphocyte antigen CD20 binding agentResearchOngoing clinical research

Also known as Columvi.

RxNorm2639782ChEMBLCHEMBL4298092ATCL01FX28UNII06P3KLK2J8
57
Active clinical trials
4
Protein targets
6
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase II Study of Glofitamab Plus Polatuzumab-R-CHP for Patients With High-risk Diffuse Large B-cell Lymphoma

Clinical trial2026-09-15Primary completion · ClinicalTrials.gov

A Phase II, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab Monotherapy and Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Clinical trial2026-09-11Results expected Q1 2027 · ClinicalTrials.gov

A Phase 2 Study of Glofitamab and Obinutuzumab for First-line Treatment of Follicular Lymphoma and Marginal Zone Lymphoma

Clinical trial2026-08-31Primary completion · ClinicalTrials.gov

A Phase II Study of Glofitamab for Relapsed/Refractory Mantle Cell Lymphoma in Patients Previously Treated With CD19-Directed CAR T-Cell Therapy

Clinical trial2026-08-24Results expected Q3 2027 · ClinicalTrials.gov

A Pilot Study to Estimate the Safety and Tolerability of the Combination of Polatuzumab Vedotin, With or Without Glofitamab, With Dose Adjusted Rituximab, Etoposide, Cyclophosphamide, and Doxorubicin (PERCH) for Upfront Treatment of Aggressive B-Cell Non-Hodgkin Lymphomas

Clinical trial2026-08-21Status changed to Active, not recruiting · ClinicalTrials.gov

A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Patients With B-Cell Non-Hodgkin Lymphoma

Clinical trial2026-08-17Status changed to Active, not recruiting · ClinicalTrials.gov

A Phase 2 Study of Axicabtagene Ciloleucel and Glofitamab as Second-Line Therapy for Relapsed or Refractory Patients With Large B Cell Lymphoma

Clinical trial2026-08-12Results expected Q3 2027 · ClinicalTrials.gov

A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed/Refractory Mantle Cell Lymphoma

Clinical trial2026-08-05Results expected Q3 2027 · ClinicalTrials.gov

Label change: GLOFITAMAB (BLA761309)

Regulatory2026-06-22FDA

Label change: GLOFITAMAB (BLA761309)

Regulatory2026-05-28FDA

Label change: GLOFITAMAB (BLA761309)

Regulatory2025-10-27FDA

Label change: GLOFITAMAB (BLA761309)

Regulatory2025-06-09FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Glofitamab
Aliases & brands
Columvi
RxNorm CUI
2639782
ChEMBL ID
CHEMBL4298092
ATC codes
L01FX28
UNII
06P3KLK2J8
Primary mechanism
B-lymphocyte antigen CD20 binding agent
Regulatory jurisdictions
emafda

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

B-lymphocyte antigen CD20
MS4A1 · P11836
BINDING AGENTB-lymphocyte antigen CD20 binding agent
T-cell surface glycoprotein CD3 epsilon chain
CD3E · P07766
BINDING AGENTT cell surface glycoprotein CD3 binding agent
T-cell surface glycoprotein CD3 gamma chain
CD3G · P09693
BINDING AGENTT cell surface glycoprotein CD3 binding agent
T-cell surface glycoprotein CD3 delta chain
CD3D · P04234
BINDING AGENTT cell surface glycoprotein CD3 binding agent

Regulatory timeline

6 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2023-06-15 → 2023-07-07)
Earliest approval
2023-06-15
Latest approval
2023-07-07
Authorities
FDA · EMA
Total events
6
fdaU.S. Food and Drug Administration· 5 events
2026-06-22Label change
Label change: GLOFITAMAB (BLA761309)
Evidence ↗
2026-05-28Label change
Label change: GLOFITAMAB (BLA761309)
Evidence ↗
2025-10-27Label change
Label change: GLOFITAMAB (BLA761309)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2023-07-07ApprovalMulti-authority
Approval: Columvi (EMA)
Indication: Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise… Show full indication

Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

66 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
66
registered trials across all phases
LATEST COMPLETION 2025
57
Active studies
42
Recruiting
4
Late-stage (III+)
4
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 66
Early Phase 11Phase 115Phase 1 / 29Phase 237Phase 33Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Prospective Clinical Study of Glofitamab for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma

Not yet recruitingPH IVZhengzhou Universityn=402028

A Phase III, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Glofitamab (RO7082859) in Combination With Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

Active, not recruitingPH IIIKey trialHoffmann-La Rochen=1,1302030

A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed/Refractory Mantle Cell Lymphoma

RecruitingPH IIIHoffmann-La Rochen=1822028

A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Active, not recruitingPH IIIHoffmann-La Rochen=2702028

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase IB, Open-Label, Multicenter, Single Arm Study Evaluating the Preliminary Efficacy, Safety, and Pharmacokinetics of Glofitamab in Combination With Rituximab Plus Ifosfamide, Carboplatin Etoposide Phosphate in Patients With Relapsed/Refractory Transplant or CAR-T Therapy Eligible Diffuse B-Cell Lymphoma

CompletedPH IHoffmann-La Rochen=432025

A Phase Ib Study Evaluating Glofitamab (RO7082859) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin (POLA) Plus Rituximab (R), Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Relapsed or Refractory Non-Hodgkin Lymphoma (R/R NHL) or in Participants With Untreated Diffuse Large B-Cell Lymphoma (DLBCL)

CompletedPH IHoffmann-La Rochen=1112024

A Phase I, Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Efficacy of Glofitamab as Single Agent Administered After a Fixed, Single Dose Pretreatment of Obinutuzumab in Chinese Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

CompletedPH IHoffmann-La Rochen=302024

A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma

CompletedPH IHoffmann-La Rochen=232021
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.