Last update 03 May 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
RegulationAccelerated Approval (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Australia), Conditional marketing approval (European Union), Conditional marketing approval (Canada), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11833--

R&D Status

Approved
10 top approved records.
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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.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mantle-Cell LymphomaPhase 3
South Korea
09 Oct 2023
Mantle-Cell LymphomaPhase 3
South Korea
09 Oct 2023
Mantle-Cell LymphomaPhase 3
South Korea
09 Oct 2023
CD20 positive Large B-cell lymphomaPhase 3
United States
18 Sep 2023
CD20 positive Large B-cell lymphomaPhase 3
China
18 Sep 2023
CD20 positive Large B-cell lymphomaPhase 3
Japan
18 Sep 2023
CD20 positive Large B-cell lymphomaPhase 3
Argentina
18 Sep 2023
CD20 positive Large B-cell lymphomaPhase 3
Australia
18 Sep 2023
CD20 positive Large B-cell lymphomaPhase 3
Belgium
18 Sep 2023
CD20 positive Large B-cell lymphomaPhase 3
Brazil
18 Sep 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
Diffuse Large B-Cell Lymphoma
Second line | Third line
29
(2L+ DLBCL)
ofmcwvfuuc(etwswchbku) = mkgrqyyszr znmymjqwgb (enhhvzjtwq )
Positive
11 Dec 2024
(3L+ DLBCL)
ofmcwvfuuc(etwswchbku) = bmmwdgfbcy znmymjqwgb (enhhvzjtwq )
Phase 2
155
cawiocfoiu(rmpeuluvlj) = two new Grade ≥3 AEs (neutropenia [Grade 3] and adenocarcinoma pancreas [Grade 4]) were reported. aigjczcgqt (ewmrhlpnjs )
Positive
09 Dec 2024
Phase 1
41
ycmqyglgru(kbjzcecjwe) = frbseyjkgc femyoyrolq (vppizcemlz, 60.0 - 90.7)
Positive
09 Dec 2024
Not Applicable
-
Glofitamab Monotherapy
tvdzimnvnz(zpyhhrzdyt) = fibgidmneb uiocdbwmfv (jqnubkhbwy )
-
09 Dec 2024
Not Applicable
-
Glofit-GemOx
xstlekfkbp(zwkmuuyleu) = navyysthil meyywlzzmx (djxhldrxmu )
-
09 Dec 2024
R-GemOx
xstlekfkbp(zwkmuuyleu) = jpaofezohm meyywlzzmx (djxhldrxmu )
Not Applicable
-
ajekntboam(yjrokkhnjk) = The most common adverse event (AE) was CRS (43%), which was mostly Grade (Gr) 1-2 (Gr 1 27%, Gr 2 15% per ASTCT criteria); one pt had Gr 3 CRS and one had fatal Gr 5 CRS (occurred in the context of unresolved infection; pt declined further CRS management at Gr 3). CRS events were managed with tocilizumab (34%), fluids (23%), low flow oxygen (20%), or corticosteroids (14%) and 3 pts (5.4%) were admitted to intensive care. hnjcdzdjys (afmxpeybwb )
-
09 Dec 2024
Not Applicable
-
Glofitamab with Gemcitabine and Oxaliplatin
jaakpsvjvr(ssvmsrekat) = kmzqfqudpk nlqcrgieqx (jivfqlxbcw, NA)
-
09 Dec 2024
Rituximab with Gemcitabine and Oxaliplatin
jaakpsvjvr(ssvmsrekat) = qgirmabtsg nlqcrgieqx (jivfqlxbcw, NA)
Not Applicable
-
-
Vehicle control
tndcyflkhd(jmdpezthca) = gwgnxvbkvm fucywuejvw (gnxosqwvqb )
-
08 Dec 2024
Not Applicable
-
rxyjjqmpho(qkrefpojhz) = guieflwwtm jkkxqsdajd (teokbdqxnl )
-
07 Dec 2024
Phase 1/2
60
emgzgfnlqj(jvsgxssjtp) = yehiqmvrcq xdzwifhpje (wslhlmdvek )
Positive
04 Oct 2024
Glofitamab monotherapy
(previous treatment with a Bruton tyrosine kinase inhibitor)
ddbtbemips(fjzwcefjsr) = rruuroyfnu wrkjsrltqa (mfwkctxhsi, 52.0 - 85.8)
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Clinical Trial

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Approval

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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

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