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COLUMVI (GLOFITAMAB-GXBM)
COLUMVI (generic name: GLOFITAMAB-GXBM) is a Bispecific CD20-directed CD3 T Cell Engager [EPC] drug developed by GENENTECH INC. It is currently FDA-approved for Relapsed or refractory diffuse large B-cell lymphoma.
At a glance
| Generic name | GLOFITAMAB-GXBM |
|---|---|
| Sponsor | GENENTECH INC |
| Drug class | Bispecific CD20-directed CD3 T Cell Engager [EPC] |
| Target | B-lymphocyte antigen CD20, T-cell surface glycoprotein CD3 epsilon chain |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Relapsed or refractory diffuse large B-cell lymphoma
Boxed warnings
- WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.3 , and 2.4) and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.2 , 2.3 , 2.4 , 5.1 )
Common side effects
- Cytokine release syndrome
- Musculoskeletal pain
- Rash
- Fatigue
- Lymphocyte count decreased
- Phosphate decreased
- Neutrophil count decreased
- Uric acid increased
- Fibrinogen decreased
- Infusion-related reaction
- Peripheral neuropathy
- Pneumonia
Serious adverse events
- Cytokine release syndrome
- COVID-19 infection
- Sepsis
- Tumor flare
- Delirium
- Neutropenia
- Infection
Key clinical trials
- A Phase I Study of Glofitamab With Alternating R-CHOP/R-DHAP in Previously Untreated Mantle Cell Lymphoma (Phase 1)
- A PHASE 1b/2, OPEN-LABEL STUDY OF PF-07901801 IN COMBINATION WITH GLOFITAMAB AFTER A FIXED, SINGLE DOSE OF OBINUTUZUMAB IN PARTICIPANTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA NOT ELIGI (Phase 1)
- A Phase 1b Study of Glofitamab in CNS Lymphoma (Phase 1)
- Phase II Study of Glofitamab Therapy in Relapsed or Refractory Diffuse Large B-cell Lymphoma Patients Achieving Response After CD19 Chimeric Antigen Receptor T-cell Therapy (Phase 2)
- A Phase II Study of Glofitamab for Relapsed/Refractory Mantle Cell Lymphoma in Patients Previously Treated With CD19-Directed CAR T-Cell Therapy (Phase 2)
- An Open-Label, Multi-Center, Phase IB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin (Plus a Single Pre-Treatment Dose of Obinutuzumab) in Adult Patients With Relapsed/Refractory B-Cel (Phase 1)
- TPG: a Phase 2 Trial of Polatuzumab Vedotin, Glofitamab, and Tafasitamab as Chemotherapy-sparing First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma (Phase 2)
- 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 (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- COLUMVI CI brief — competitive landscape report
- COLUMVI updates RSS · CI watch RSS
- GENENTECH INC portfolio CI
Frequently asked questions about COLUMVI
What is COLUMVI?
COLUMVI (GLOFITAMAB-GXBM) is a Bispecific CD20-directed CD3 T Cell Engager [EPC] drug developed by GENENTECH INC, indicated for Relapsed or refractory diffuse large B-cell lymphoma.
What is COLUMVI used for?
COLUMVI is indicated for Relapsed or refractory diffuse large B-cell lymphoma.
Who makes COLUMVI?
COLUMVI is developed and marketed by GENENTECH INC (see full GENENTECH INC pipeline at /company/roche).
What is the generic name of COLUMVI?
GLOFITAMAB-GXBM is the generic (nonproprietary) name of COLUMVI.
What drug class is COLUMVI in?
COLUMVI belongs to the Bispecific CD20-directed CD3 T Cell Engager [EPC] class. See all Bispecific CD20-directed CD3 T Cell Engager [EPC] drugs at /class/bispecific-cd20-directed-cd3-t-cell-engager-epc.
What development phase is COLUMVI in?
COLUMVI is FDA-approved (marketed).
What are the side effects of COLUMVI?
Common side effects of COLUMVI include Cytokine release syndrome, Musculoskeletal pain, Rash, Fatigue, Lymphocyte count decreased, Phosphate decreased. Serious adverse events: Cytokine release syndrome, COVID-19 infection, Sepsis, Tumor flare.
What does COLUMVI target?
COLUMVI targets B-lymphocyte antigen CD20, T-cell surface glycoprotein CD3 epsilon chain and is a Bispecific CD20-directed CD3 T Cell Engager [EPC].
Related
- Drug class: All Bispecific CD20-directed CD3 T Cell Engager [EPC] drugs
- Target: All drugs targeting B-lymphocyte antigen CD20, T-cell surface glycoprotein CD3 epsilon chain
- Manufacturer: GENENTECH INC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Relapsed or refractory diffuse large B-cell lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing