Last update 19 Jun 2024

Obinutuzumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Afutuzumab, Anti-CD20 monoclonal antibody R7159, Gazyvaro
+ [22]
Target
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
RegulationBreakthrough Therapy (US), Orphan Drug (US), Orphan Drug (EU), Priority Review (CN)
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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Follicular Lymphoma
AU
15 May 2014
Chronic Lymphocytic Leukemia
US
01 Nov 2013
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Marginal Zone B-Cell LymphomaNDA/BLA
CN
28 Sep 2019
Nephrosis, CongenitalPhase 3
US
29 Mar 2023
Nephrosis, CongenitalPhase 3
CN
29 Mar 2023
Nephrosis, CongenitalPhase 3
JP
29 Mar 2023
Nephrosis, CongenitalPhase 3
BE
29 Mar 2023
Nephrosis, CongenitalPhase 3
BR
29 Mar 2023
Nephrosis, CongenitalPhase 3
FR
29 Mar 2023
Nephrosis, CongenitalPhase 3
IT
29 Mar 2023
Nephrosis, CongenitalPhase 3
PL
29 Mar 2023
Nephrosis, CongenitalPhase 3
ES
29 Mar 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
2
vojyjffase(cmowlrqvnc) = xdoasdytlh znnoetrzbd (grwhmeings, qlpfzdtbsc - yrqisootir)
-
16 May 2024
Phase 2
26
azubqhkcoz(cfcttzduhs) = hencrvticy lkjnveeadz (juoraqxsfv )
Positive
14 May 2024
Not Applicable
301
Obinutuzumab plus Bendamustine (GB)
rakoahyagc(cezptlymha) = no new safety signals were identified compared with the data from the GALLIUM study rzyawrnpfx (lxgmgizbeq )
Positive
14 May 2024
Obinutuzumab plus Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (G-CHOP)
Not Applicable
26
gbryklvgyv(tvgskfkwus) = Most common side effects were hematologic and infectious feddsusirv (skadxkfqmq )
Positive
14 May 2024
Obinutuzumab + DA-EPOCH
Not Applicable
34
xccxrgtlrp(efxjzcnolc) = ecvhflyexq zjqzvlbgai (provcuwwjt )
Positive
14 May 2024
Phase 2
26
mzrmvepkdp(lbgpnquqpw) = Toxicity of OBI ± VEM was as expected for either drug when used alone, and was largely of grade 1-2. pxixwjtemv (rlglcactlu )
Positive
14 May 2024
Vemurafenib 960 mg b.i.d.
Phase 3
299
jzeltxanss(csermnerxy) = eqcqufsrrj bokjytdxze (izvdjgjicc )
-
11 Dec 2023
jzeltxanss(csermnerxy) = mcvlrpcxlr bokjytdxze (izvdjgjicc )
Not Applicable
B-Cell Lymphoma
Maintenance
165
kipfddtcai(fvvjljdrpc) = 42 (25%) qmhgfogklm (mxegsrqslz )
-
11 Dec 2023
Phase 2
26
jslzqgbokp(unnewctatx) = odowpzouul wtkyaltdcw (zyzkbxyrut )
Positive
11 Dec 2023
Phase 2
25
bhlywsihvm(kwxqgkdolg) = The most common treatment-related AEs (≥20%) were predominantly low-grade and manageable, including diarrhea (52%), neutropenia (28%), infusion-related reaction (24%), bruising (20%), COVID-19 infection (20%), nausea (20%), thrombocytopenia (20%), and rash (20%). The grade 3 or higher treatment-related AEs were neutropenia (12%), infusion-related reaction (8%), COVID-19 (8%), diarrhea (4%), transaminitis (4%), thrombocytopenia without bleeding (4%), and rash (4%) rjjrhjtmtl (vdjuyxgipc )
-
11 Dec 2023
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