Glofitamab 2.5mg/2.5ml solution for infusion vials
Requires a prescription from a doctor or prescriber
Glofitamab is a full-length bispecific monoclonal antibody with affinity for both CD20 and CD3 surface antigens found on B- and T-cells, respectively.
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Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Glofitamab
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Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
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Suspected adverse reactions reported for Glofitamab
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1 branded products available
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Columvi 2.5mg/2.5ml concentrate for solution for infusion vials
Therapeutically similar medicines
Similarity is based on WHO Anatomical Therapeutic Chemical (ATC) classification and on a factual NHS dm+d therapeutic-grouping code prefix. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Guidelines from the National Institute for Health and Care Excellence
NICE clinical guidance(6)
Glofitamab for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic treatments (TA927)
Glofitamab with gemcitabine and oxaliplatin for treating relapsed or refractory diffuse large B-cell lymphoma (TA1113)
Non-Hodgkin lymphoma: diagnosis and management (NG52)
Loncastuximab tesirine for treating relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma after 2 or more systemic treatments (TA947)
Epcoritamab for treating relapsed or refractory diffuse large B-cell lymphoma after 2 or more systemic treatments (TA954)
Lisocabtagene maraleucel for treating relapsed or refractory large B-cell lymphoma after first-line chemoimmunotherapy when a stem cell transplant is suitable (TA1048)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
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Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
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SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Academic studies and reviews for this medicine's active substance
Showing the 50 most relevant studies.
Reviews & meta-analyses: 5 · Randomised trials: 4 · 2021–2026
Showing the 50 most relevant studies, sorted by most relevant.
J. Abramson, M. Ku, M. Hertzberg, et al.
Lancet, 2024
Huang L, Chen K, Wang M, et al.
2026
BackgroundThe advent of novel therapies including chimeric antigen receptor (CAR) T cells, bispecific antibodies (BsAbs), and antibody-drug conjugates (ADCs), has markedly improved clinical outcomes for relapsed or refractory large B-cell lymphoma (R/R LBCL). However, direct comparisons of efficacy and safety among systemic treatments for R/R LBCL are lacking, complicating clinical decision-making.MethodsA systematic literature search was conducted across PubMed, Embase, and the Cochrane Library to identify eligible randomized controlled trials (RCTs). A Bayesian network meta-analysis (NMA) was performed to evaluate the systemic therapies across transplant-eligible and transplant-ineligible patients with R/R LBCL. The primary endpoint was progression-free survival (PFS), secondary endpoints included event-free survival (EFS), overall survival (OS), objective response rate (ORR) and grade ≥3 treatment-emergent adverse events (TEAEs).ResultsThe analysis included 14 RCTs comprising a total of 3,329 patients. Among the transplant-eligible cohort (7 evaluated regimens), CAR-T therapies maximized disease control; lisocabtagene maraleucel (liso-cel) ranked highest for PFS [hazard ratio (HR) =0.42; 95% credible intervals (CrI): 0.28-0.64] and EFS (HR =0.37, 95% CrI: 0.26-0.54), whereas axicabtagene ciloleucel (axi-cel) was associated with the highest incidence of grade ≥3 TEAEs [risk ratio (RR) =2.09; 95% CrI: 1.08-4.19]. In the transplant-ineligible cohort (9 evaluated regimens), glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) ranked highest for PFS (HR =0.32; 95% CrI: 0.23-0.45), while polatuzumab vedotin plus bendamustine and rituximab (Pola-BR) yielded the maximum benefit for OS (HR =0.42; 95% CrI: 0.24-0.73) and ORR [odds ratio (OR) =5.21; 95% CrI: 2.01-14.3]. Both regimens were associated with higher toxicities, but remained overall manageable.ConclusionsThis NMA provides a comprehensive comparison of systemic treatment strategies for R/R LBCL regarding efficacy and safety profiles.
Abstract licence: CC BY-NC-ND
M. Dickinson, C. Carlo-Stella, F. Morschhauser, et al.
The New England journal of medicine, 2022
M. Hutchings, F. Morschhauser, G. Iacoboni, et al.
Journal of Clinical Oncology, 2021
Tycel J. Phillips, Matthew Matasar, Toby A. Eyre, et al.
Blood, 2023
Adrian Minson, Emma Verner, Pratyush Giri, et al.
Blood, 2024
Yin-Yin Peng, Xiao-qiong Tang
Blood, 2025
Jingyi Yang, Qian Shen, Xiaoyan Ke, et al.
Clinical Pharmacology: Advances and Applications, 2025
Glofitamab is a novel bispecific antibody targeting CD20×CD3, capable of simultaneously targeting CD20 and CD3 to activate T cells and release cytotoxic proteins that kill cancer cells. Cytokine release syndrome (CRS) is one of the most common adverse events observed in clinical trials of glofitamab. In most cases, CRS is mild, transient, and manageable with appropriate treatment. This paper reports a case of persistent CRS in a patient with mantle cell lymphoma following glofitamab treatment and reviews the relevant literature for reference.
Abstract licence: CC BY-NC 3.0
Jan Miko Aaron Baybay, P Caguioa
Clinical Lymphoma Myeloma and Leukemia, 2025
Jan Miko Aaron Baybay, P Caguioa
Clinical Lymphoma Myeloma and Leukemia, 2025
Sources: aggregated from Europe PMC (EMBL-EBI), OpenAlex, Crossref, PubMed and other open scholarly databases. Retracted articles are excluded. Study information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
1.56 days
Mechanism
Glofitamab is a bispecific monoclonal antibody targeted towards CD20 surface ant…
Food interactions
None known
Human targets
2 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
2.5 mg
Half-life
1.56 days
Volume of distribution
3.33 L
Metabolism
[L45698]
…
Clearance
0.602 L
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Glofitamab was approved by Health Canada in March 2023 for the treatment of certain patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), becoming the first CD20/CD3 bispecific monoclonal antibody approved for DLBCL.[L45768] The most common type of non-Hodgkin lymphoma,[L45763] DLBCL is relatively sensitive to chemotherapy and generally responsive to first-line treatment regimens like CHOP ([cyclophosphamide], [doxorubicin], [vincristine], [prednisone])[L45763] - despite this, as many as 40% of patients will experience relapsed or refractory disease.[L45768][A258433] In the context of relapsed or refractory DLBCL, glofitamab provides an alternative treatment option for patients having failed other systemic therapies or for whom targeted therapies - such as CAR-T cell therapy - are inappropriate.
In June 2023, the FDA approved the use of glofitamab for the treatment of patients with relapsed or refractory DLBCL not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy under accelerated approval based on response rate and durability of response.[L47047][L47052]
Glofitamab was granted conditional marketing authorization in July 2023 by the EMA for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. This approval is based on the positive results obtained from the phase I/II NP30179 study, where 35.2% of study participants achieved a complete response.[L47451]
[L45698]
The FDA approved glofitamab under accelerated approval for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.
[L47052]
Glofitamab was also approved by the EMA to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
[L47446]
Known interactions with other medicines. Always consult a healthcare professional.
Showing 50 of 1364 interactions
[L45698]
Glofitamab can cause cytokine release syndrome (CRS) which may be serious or life-threatening in some patients.[L45698] To limit the risk of CRS, prescribing information states that all patients must receive pre-treatment with [obinutuzumab] seven days prior to beginning treatment with glofitamab. In addition, patients should be well-hydrated and should receive a premedication regimen comprising a glucocorticoid, analgesic/antipyretic, and/or antihistamine, dependent on the patient and the cycle.[L45698] The dose of glofitamab should be titrated gradually and according to prescribing information to further limit the risk of CRS, and patients should be monitored for 10 hours following the first infusion and as required thereafter.
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L45698]
Non-compartmental analysis following a single dose of 10 mg showed a geometric mean Cmax of 2.34 µg/mL, Tmax of 8.05, and AUCinf of 244 hr*µg/mL.
[L45698]
[L45698]
[L45698]
[L45698]
[L45698]
Proteins and enzymes this drug interacts with in the body
PMID:12920111 PMID:3925015 PMID:7684739
Functions as a store-operated calcium (SOC) channel component promoting calcium influx after activation by the B-cell receptor/BCR PMID:12920111 PMID:18474602 PMID:7684739
Upon TCR engagement, these motifs become phosphorylated by Src family protein tyrosine kinases LCK and FYN, resulting in the activation of downstream signaling pathways .
PMID:1384049 PMID:1385158 PMID:2470098 PMID:7509083
CD3Z ITAMs phosphorylation creates multiple docking sites for the protein kinase ZAP70 leading to ZAP70 phosphorylation and its conversion into a catalytically active enzyme .
PMID:7509083
Plays an important role in intrathymic T-cell differentiation. Additionally, participates in the activity-dependent synapse formation of retinal ganglion cells (RGCs) in both the retina and dorsal lateral geniculate nucleus (dLGN) (By similarity)
ATC L01FX28
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Glofitamab
Additional database identifiers
Drugs Product Database (DPD)
23828
HUGO Gene Nomenclature Committee (HGNC)
HGNC:7315
GenAtlas
MS4A1
GeneCards
MS4A1
GenBank Gene Database
X12530
GenBank Protein Database
29774
Guide to Pharmacology
2628
UniProt Accession
CD20_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1673
GenAtlas
CD3D
GeneCards
CD3D
GenBank Gene Database
X01451
UniProt Accession
CD3D_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1674
GenAtlas
CD3E
GeneCards
CD3E
GenBank Gene Database
X03884
GenBank Protein Database
469945
Guide to Pharmacology
2742
UniProt Accession
CD3E_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1675
GenAtlas
CD3G
GeneCards
CD3G
GenBank Gene Database
BC113830
UniProt Accession
CD3G_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:1677
GenAtlas
CD247
GeneCards
CD247
GenBank Gene Database
BC025703
UniProt Accession
CD3Z_HUMAN
DrugBank citations
If you use DrugBank data in your research, please cite:
- DrugBank 6.02024Recommended citationKnox C., Wilson M., Klinger C.M., et alDrugBank 6.0: the DrugBank Knowledgebase for 2024Nucleic Acids Res. 2024 Jan 552(D1):D1265-D1275
- DrugBank 5.02018Wishart D.S., Feunang Y.D., Guo A.C., et alDrugBank 5.0: a major update to the DrugBank database for 2018Nucleic Acids Res. 2017 Nov 846(D1):D1074-D1082
- DrugBank 4.02014Law V., Knox C., Djoumbou Y., et alDrugBank 4.0: shedding new light on drug metabolismNucleic Acids Res. 2014 Jan 142(1):D1091-7
- DrugBank 3.02011Knox C., Law V., Jewison T., et alDrugBank 3.0: a comprehensive resource for 'omics' research on drugsNucleic Acids Res. 2011 Jan39(Database issue):D1035-41
- DrugBank 2.02008Wishart D.S., Knox C., Guo A.C., et alDrugBank: a knowledgebase for drugs, drug actions and drug targets.Nucleic Acids Research2008 Jan36(Database issue):D901-6
- DrugBank 1.02006Wishart D.S., Knox C., Guo A.C., et alDrugBank: a comprehensive resource for in silico drug discovery and exploration.Nucleic Acids Research2006 Jan 134(Database issue):D668-72