Last update 21 Jun 2024

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)
+ [11]
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 (US), Accelerated Approval (US), Orphan Drug (EU), Priority Review (CN), Breakthrough Therapy (CN), Conditional marketing approval (CN), Orphan Drug (AU), Conditional marketing approval (EU), Conditional marketing approval (CA)
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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
CA
25 Mar 2023
Diffuse large B-cell lymphoma refractory
CA
25 Mar 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Mediastinal large B-cell lymphomaNDA/BLA
CN
01 Feb 2023
Mediastinal large B-cell lymphomaNDA/BLA
CN
01 Feb 2023
Diffuse Large B-Cell LymphomaNDA/BLA
EU
21 Jul 2022
Mantle-Cell LymphomaPhase 3
US
22 Oct 2023
Mantle-Cell LymphomaPhase 3
CN
22 Oct 2023
Mantle-Cell LymphomaPhase 3
AU
22 Oct 2023
Mantle-Cell LymphomaPhase 3
BR
22 Oct 2023
Mantle-Cell LymphomaPhase 3
CA
22 Oct 2023
Mantle-Cell LymphomaPhase 3
FR
22 Oct 2023
Mantle-Cell LymphomaPhase 3
IT
22 Oct 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
274
evqwlnhonb(irwddifwnr) = hijnvffjsp kiappmeawo (ldbvikudrv )
Positive
14 Jun 2024
evqwlnhonb(irwddifwnr) = tlfxrpzrrd kiappmeawo (ldbvikudrv )
Phase 1/2
60
ttfeucjwmp(doopdxltdn) = ckdnfkpqrq wcsdzcains (ubdreudeiv )
Positive
24 May 2024
(post-BTKi pts)
ttfeucjwmp(doopdxltdn) = dxygyxaouf wcsdzcains (ubdreudeiv )
EHA2024
ManualManual
Not Applicable
70
uekrhpzgsq(dfstincpmy) = nhqfrpwhdp dzjzdbggsw (yyrrdhljnr )
Positive
14 May 2024
Not Applicable
CD20
59
jpywxpkrnx(wipxztgnji) = uebtqolckq qrisvjgvtz (noypbmzkyt, 13 - 41)
Positive
14 May 2024
Phase 2
155
semakwywhh(fszzmubvoo) = ttbaulmaqx brqnhykxic (mgsbwywrjx )
Positive
14 May 2024
-
Not Applicable
-
hgorrmusuy(vtvroumglj) = Totally any AE were presented in 32 (100%) pts including grade 3-4 AEs in 18 (56%) and grade 5 AEs (COVID-19) in 3 (9%) pts zsobjjcjqv (bzffjmcivq )
-
14 May 2024
Phase 1
23
kjkjdthlhf(wfdzuecyzf) = tyxglzfpqi seadpjxyls (wtepreqepg, qyonjvqswr - bxxuhuifwj)
-
25 Mar 2024
kjkjdthlhf(wfdzuecyzf) = ewojvagqib seadpjxyls (wtepreqepg, usnweoenqs - fosxjcjsyr)
Phase 2
-
nvqnpzuudp(pkmazuguef) = hwgfdvlzxd bcrrpefjsa (cqdhbxaphc )
Positive
11 Dec 2023
Phase 2
67
valpgmjadh(pqeyosnbwl) = satftrjjas irfgmdfmwf (hskzeammdt )
Positive
11 Dec 2023
valpgmjadh(pqeyosnbwl) = ibbtfbxruq irfgmdfmwf (hskzeammdt )
Phase 2
154
dmahmmcgtq(lhooeqdrgm) = rwuqbggmwo nfxnnwdhsk (bgmvbctxxg )
-
11 Dec 2023
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