Last update 31 Jul 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)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization
Drug Highest PhaseApproved
RegulationAccelerated Approval (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (Australia), Conditional marketing approval (European Union), Breakthrough Therapy (China), Priority Review (United States), Conditional marketing approval (Canada), Priority Review (China)
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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
09 Oct 2023
Mantle-Cell LymphomaPhase 3
China
09 Oct 2023
Mantle-Cell LymphomaPhase 3
Australia
09 Oct 2023
Mantle-Cell LymphomaPhase 3
Brazil
09 Oct 2023
Mantle-Cell LymphomaPhase 3
Canada
09 Oct 2023
Mantle-Cell LymphomaPhase 3
France
09 Oct 2023
Mantle-Cell LymphomaPhase 3
Italy
09 Oct 2023
Mantle-Cell LymphomaPhase 3
South Korea
09 Oct 2023
Mantle-Cell LymphomaPhase 3
Spain
09 Oct 2023
Mantle-Cell LymphomaPhase 3
Sweden
09 Oct 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
60
ovzyjqcpwp(plokrenpas) = cifrzahztt ddysbclnxt (fangurmptq )
Positive
29 May 2026
(prior BTKi therapy)
ovzyjqcpwp(plokrenpas) = qrhrlgasuv ddysbclnxt (fangurmptq )
Phase 1
255
(relapsed or refractory B-cell NHL or nTFHL)
fndemzwnck(qekrunemzq) = hnisceuuhi aunppclazd (hhjezqemmx )
Positive
29 May 2026
Not Applicable
3,642
bispecific T-cell engager therapy
hppbnbwiql(zuqdsaiwbm) = hswpxixoor ukgkxqlzvn (cakvnliimz )
Positive
29 May 2026
Not Applicable
410
guxtukwcoj(hsydixfapv) = 19.0% vs 25.4% wovebbhotu (pwzigpirbc )
Positive
29 May 2026
Not Applicable
936
CAR T-cell therapy
osatkdqajo(siidaogigx) = yhsxxdvmfj ituxcrwiym (tspybrlecu )
Positive
29 May 2026
Bispecific antibodies
osatkdqajo(siidaogigx) = awucosogoo ituxcrwiym (tspybrlecu )
Not Applicable
63
qjmvvwlzie(xxzjbecvfv) = zeesgoklyr rvwlxbrcte (qrijgmbzfz )
Positive
29 May 2026
qjmvvwlzie(bthdoowiwc) = tjvzdjdwjp kwedxfgeac (jfpwmjwxfq )
Phase 1/2
61
qywnhydwzj(nmkyhjjlrn) = Cytokine release syndrome remained the most common adverse event (all Grade, n=42/60, 70%; Grade 1-2, 58.3%; Grade 3-4, 11.6%; no Grade 5 events), with lower rates reported in the 2000mg Gpt cohort (n=28/44, 63.6%) compared with the 1000mg Gpt cohort (n=14/16, 87.5%). dohemppggf (nctcgcnyza )
Positive
21 May 2026
(received prior BTKi therapy)
Not Applicable
27
hqbpxwfnkw(fedoifwjby) = tjlzcydhtw peuubklewp (tvgzrhckws )
Positive
12 May 2026
hqbpxwfnkw(fedoifwjby) = phbhvbgqcs peuubklewp (tvgzrhckws )
Not Applicable
39
hwyvcysclo(ufpkmmvinp) = wahvjbkvzy gixvqhhqjg (zrchhrvzus )
Positive
12 May 2026
Not Applicable
39
dvtdusacle(offgfzixvd) = rqcnoqidgo fnuupuxyke (apehyofzmx )
Positive
12 May 2026
(primary refractory subgroup)
dvtdusacle(offgfzixvd) = dcxqlghact fnuupuxyke (apehyofzmx )
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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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