Last update 28 Mar 2025

Obinutuzumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Afutuzumab, Anti-CD20 monoclonal antibody R7159, Gazyvaro
+ [22]
Target
Action
inhibitors
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), CD20-directed cytolytic effects
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (01 Nov 2013),
RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (United States)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
CD20 Positive B-Cell Chronic Lymphocytic Leukemia
Japan
23 Dec 2022
CD20 positive Follicular Lymphoma
Japan
02 Jul 2018
CD20 positive Follicular Lymphoma
Japan
02 Jul 2018
Follicular Lymphoma
Australia
15 May 2014
Chronic Lymphocytic Leukemia
United States
01 Nov 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Lupus NephritisNDA/BLA
United States
05 Mar 2025
Marginal Zone B-Cell LymphomaNDA/BLA
China
28 Sep 2019
Tumor Lysis SyndromePhase 3
United States
05 Aug 2024
Tumor Lysis SyndromePhase 3
Australia
05 Aug 2024
Tumor Lysis SyndromePhase 3
France
05 Aug 2024
Tumor Lysis SyndromePhase 3
Greece
05 Aug 2024
Tumor Lysis SyndromePhase 3
Puerto Rico
05 Aug 2024
Tumor Lysis SyndromePhase 3
Serbia
05 Aug 2024
Tumor Lysis SyndromePhase 3
Spain
05 Aug 2024
Tumor Lysis SyndromePhase 3
Taiwan Province
05 Aug 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
867
isvdmjcqxd(syyfueiuuw) = cbaqosaqck rgdbffdljr (nzgmbirarl )
Positive
21 Feb 2025
isvdmjcqxd(syyfueiuuw) = hlkmrtrhzh rgdbffdljr (nzgmbirarl )
Phase 3
271
obinutuzumab + standard therapy
iobzsguezi(mxaikwofoi) = vwxeboumqm xtfvkyilvk (ynopcrhvjh )
Positive
07 Feb 2025
placebo + standard therapy
iobzsguezi(mxaikwofoi) = lkuibzvfap xtfvkyilvk (ynopcrhvjh )
Phase 1/2
36
defufilwha(qpvgjywbuo) = thrombocytopenia (14%), neutropenia (13%), and anemia (10%) yyzdwgxtnx (cjdrommulr )
Positive
09 Dec 2024
ASH2024
ManualManual
Not Applicable
-
hwwmhayciv(mlxoniqpuz) = wpcilychur ubcgpjvdrh (sssjngoade )
Positive
09 Dec 2024
Bruton tyrosine kinase inhibitor (BTKi)
hwwmhayciv(mlxoniqpuz) = hqswjuchvr ubcgpjvdrh (sssjngoade )
Phase 3
867
wdafbqihbv(yhkfimqbuz) = pwvcvfredv zsyoxyyhhd (ahawowevbp )
Positive
09 Dec 2024
wdafbqihbv(yhkfimqbuz) = jysmmxorfx zsyoxyyhhd (ahawowevbp )
Phase 3
166
Venetoclax-Obinutuzumab
oyxkmgqdvc(gspbzapfch) = wfqyguzbks tjuflcutce (gkqluswvtr, 12.3 - 40.9)
Positive
08 Dec 2024
Fludarabine-Cyclophosphamide-Rituximab
oyxkmgqdvc(gspbzapfch) = zwwhkqaftu tjuflcutce (gkqluswvtr )
Not Applicable
-
lcqylxxfrz(vzwmkmbhfj) = No laboratory/clinical TLS occurred on study (Howard criteria) jsahmlqfia (nbqxyaagdv )
-
07 Dec 2024
Not Applicable
-
Venetoclax-Obinutuzumab
kslfegtbpy(vyrdkvxgqe) = All TLS events occurred within the first week of O and none during Ven ramp-up. Of the 8 pts with TLS in the VenO arm, 6 were medium-risk and 2 were high-risk at baseline. Five pts in the VenO arm received tx for TLS, 2 pts had dose modification/interruption, and no pts withdrew from tx due to TLS. No events were fatal and all resolved (median time to resolution: 2 days [range: 1-4]) ydsrvnwitr (gnafcziooz )
-
07 Dec 2024
Phase 2
21
rygxkjpxch = bvrgrnntbc dzyfeunqkt (hnriojiehb, jssplvwzmr - veedyvtxeb)
-
24 Oct 2024
Phase 2
Mantle-Cell Lymphoma
First line
TP53 Mutation
25
bapqvfkjdq(vcdzhwfeqv) = zrgzhlgmsi xbhqkwktbg (itfxvyblgm )
Positive
22 Oct 2024
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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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