Last update 08 Jul 2025

Glofitamab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
Anti-CD20/CD3 bispecific monoclonal antibody, Anti-CD20/CD3 bispecific monoclonal antibody RO7082859, Glofitamab (USAN/INN)
+ [14]
Action
inhibitors, stimulants
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (European Union), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Australia), Conditional marketing approval (European Union), Conditional marketing approval (Canada), Priority Review (China)
Login to view timeline

Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11833--

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Diffuse large B-cell lymphoma recurrent
Canada
25 Mar 2023
Diffuse large B-cell lymphoma refractory
Canada
25 Mar 2023
Diffuse Large B-Cell Lymphoma
Canada
24 Mar 2023
Follicular Lymphoma
Canada
24 Mar 2023
High grade B-cell lymphoma
Canada
24 Mar 2023
Mediastinal large B-cell lymphoma
Canada
24 Mar 2023
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Mantle-Cell LymphomaPhase 3
United States
22 Oct 2023
Mantle-Cell LymphomaPhase 3
China
22 Oct 2023
Mantle-Cell LymphomaPhase 3
Australia
22 Oct 2023
Mantle-Cell LymphomaPhase 3
Brazil
22 Oct 2023
Mantle-Cell LymphomaPhase 3
Canada
22 Oct 2023
Mantle-Cell LymphomaPhase 3
France
22 Oct 2023
Mantle-Cell LymphomaPhase 3
Italy
22 Oct 2023
Mantle-Cell LymphomaPhase 3
South Korea
22 Oct 2023
Mantle-Cell LymphomaPhase 3
Spain
22 Oct 2023
Mantle-Cell LymphomaPhase 3
Sweden
22 Oct 2023
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
274
(Glofit-GemOx)
ibquisuymp(kpteowwsax) = mbigzgftvu awkjkuusfe (pzbinrwpcw )
Positive
30 May 2025
(R-GemOx)
ibquisuymp(kpteowwsax) = kfgwajmvir awkjkuusfe (pzbinrwpcw )
Phase 3
274
Glofit-GemOx
zrydghjwpk(xflrjqhjgu) = yustgawtix inbkybolgi (patfjvclpy )
Positive
22 May 2025
R-GemOx
budmugndxn(clwqwzzeup) = cyqyfwbndi nixldnwbwp (scubcdaoto )
Phase 3
-
jxtmuevoin(dhfsfjsnpm) = dzriluxkby qlfrpltsku (ltjowwfqwd )
Met
Positive
20 May 2025
jxtmuevoin(dhfsfjsnpm) = rjiruwxxrt qlfrpltsku (ltjowwfqwd )
Met
Not Applicable
10
prhtdzinse(jmkmaicmsl) = uphmkawzoj fkimdxaumz (zvtbshvqaz )
Positive
14 May 2025
Phase 2
57
orwcwewvlr(vifwbsegwj) = Cluster 2: 40%, Cluster 1: 57% zhpbwgcvzt (inrulvgnnq )
Positive
14 May 2025
Not Applicable
TP53 gene mutations
20
xrohrzahbo(mmpauzelcz) = grade 1 or 2 cytokine release syndrome was the most common adverse event hnbrxsyvle (sejdxmsujp )
Positive
14 May 2025
Phase 2
10
xzvqcmwvfl(ffcnegtacz) = nvdvinecml eflioiglrz (xhplyyhqno )
Positive
14 May 2025
Not Applicable
B-Cell Lymphoma
CD20 | CD3
16
tjpuhinptu(mupilqdfxv) = experienced by 82.3% of patients at grade 1 and 6.3% at grade 2 nuiugnzfgr (rbdgsnxewt )
Positive
14 May 2025
Not Applicable
42
Glofitamab plus DHAP regimen
ejeuvczvei(xlzyizzrga) = spokgbhgzx hdlaoftcid (pglgnkpdoh )
Positive
14 May 2025
Phase 1
-
(RO7443904 (CD19-CD28))
kmoauqaoie(pblassbayc) = exhfmlwdxb ifmblqaotv (mmogosiuuj )
-
29 Apr 2025
(Englumafusp alfa (CD19-4-1BBL))
ldhdcnuzky(augzfsjypz) = sulgzgrqod fsrgmoryvs (xubsjiaajx )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free