Last reviewed · How we verify
Columvi (glofitamab)
Columvi works by binding to the CD20 protein on B-cell lymphoma cells, triggering an immune response to destroy the cancer cells.
At a glance
| Generic name | glofitamab |
|---|---|
| Sponsor | Roche |
| Drug class | Bispecific CD20-directed CD3 T Cell Engager [EPC] |
| Target | B-lymphocyte antigen CD20 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2023 |
| Annual revenue | 300 |
Mechanism of action
Glofitamab-gxbm is bispecific antibody that binds to CD20 expressed on the surface of cells, and to CD3 receptor expressed on the surface of cells. Glofitamab-gxbm causes T-cell activation and proliferation, secretion of cytokines, and the lysis of CD20-expressing cells. Glofitamab-gxbm showed anti-tumor activity in vivo in mouse models of DLBCL.
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
- Pyrexia
- Edema
- Constipation
Key clinical trials
- Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma (PHASE1)
- Gut Microbiome in DLBCL Treated With Glofitamab
- Glofitamab in Chinese Patients With R/R DLBCL
- A Study of Glofitamab and Lenalidomide in People With Mantle Cell Lymphoma (PHASE1)
- A Study to Learn About the Effects of Two Study Medicines (Maplirpacept [PF-07901801] And Glofitamab) When Given Together In People With Relapsed Or Refractory Diffuse Large B Cell Lymphoma. (PHASE1,PHASE2)
- Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy (PHASE2)
- A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (PHASE1)
- Efficacy and Safety of Glofitamab Combined With GemOxin the Treatment of Refractory Diffuse Large B-Cell Lymphoma (PHASE2)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
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
- Roche portfolio CI