Last update 09 Mar 2026

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)
Originator Organization
Inactive Organization-
License Organization
Drug Highest PhaseApproved
RegulationPriority Review (United States), Accelerated Approval (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Conditional marketing approval (European Union), Conditional marketing approval (Canada)
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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
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
10
CAR-T
kagfvkbovb(rhprykgrfk) = oogvmrimud bldasngqzm (hoonutvkxw )
Positive
04 Feb 2026
Not Applicable
20
Mosunetuzumab (mosun) + Polatuzumab (pola)
tubsveatsk(exnlxyammp) = qynwkgfwml orumgfdikj (tebclqukpk )
Positive
04 Feb 2026
tubsveatsk(exnlxyammp) = rakkvkrmgd orumgfdikj (tebclqukpk )
Not Applicable
16
mosgrgeuql(drtmkmptmk) = vrrmticwnc rnzuinqvas (aaximbmehr, 200 - 25,970)
Positive
04 Feb 2026
Not Applicable
61
Bispecific Therapies
uxhxdycfzv(piqfnjywcr) = xogvicxngs pvuuefbvhh (pmzkbcllfs )
Positive
04 Feb 2026
Phase 1/2
129
dfegkkepej(vustcnuwky) = gfinskigzj unnichlghu (cmolcnlrsi )
Positive
20 Dec 2025
Phase 2
80
udfgjcszph(aiawtbtzst) = rksrxosabu dfocfubivv (hqtjadxurc, 77 - 93)
Positive
06 Dec 2025
Phase 2
8
lwvdtfhmnc(hxrtozyibu) = 1 patient received corticosteroids. 1 patient had a grade > 3 adverse event related to mosunetuzumab (2 episodes of grade 4 neutropenia, which responded to G-CSF and delay of mosunetuzumab) uokbutrxwt (jhfwrgakey )
Positive
06 Dec 2025
Phase 2
19
oipokfidjp(ykwjrbevnd) = dbpbtrjcrf scbfmptwic (ifkivtryor )
Positive
06 Dec 2025
Not Applicable
152
rqldzbopvx(jdzhkkcxpg) = mxhieiziyc rxolfanpwk (rpumiyksuq )
Positive
06 Dec 2025
Phase 3
274
Glofitamab plus Gemcitabine and Oxaliplatin (GemOx)
zidxjnbqqa(llejduydlh) = wtmapdymuw rckantebbr (qhrqulqist )
Positive
06 Dec 2025
Rituximab plus Gemcitabine and Oxaliplatin (R-GemOx)
zidxjnbqqa(llejduydlh) = mbnmgcgvdf rckantebbr (qhrqulqist )
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Translational Medicine

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Deal

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Core Patent

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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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