Last update 21 Nov 2024

Mosunetuzumab

Overview

Basic Info

Drug Type
Bispecific T-cell Engager (BiTE)
Synonyms
Anti-CD20/CD3 T-cell dependent bispecific antibody, CD20/CD3 BiMAb, MOSUNETUZUMAB-AXGB
+ [11]
Mechanism
CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors), CD3 stimulants(T cell surface glycoprotein CD3 stimulants)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
EU (03 Jun 2022),
RegulationConditional marketing approval (EU), Orphan Drug (EU), Breakthrough Therapy (US), Priority Review (US), Accelerated Approval (US)
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External Link

KEGGWikiATCDrug Bank
D11463--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Follicular Lymphoma
IS
03 Jun 2022
Follicular Lymphoma
NO
03 Jun 2022
Follicular Lymphoma
LI
03 Jun 2022
Follicular Lymphoma
EU
03 Jun 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Follicular LymphomaNDA/BLA
CN
07 Dec 2023
Follicular LymphomaNDA/BLA
CN
07 Dec 2023
Follicular LymphomaNDA/BLA
CN
07 Dec 2023
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
PE
12 Apr 2022
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
TH
12 Apr 2022
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
RU
12 Apr 2022
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
IL
12 Apr 2022
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
RU
12 Apr 2022
Aggressive B-Cell Non-Hodgkin LymphomaPhase 3
PE
12 Apr 2022
Diffuse Large B-Cell LymphomaPhase 3
US
-
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
uzjacuzwdo(thdtafsrxj) = B-cell recovery to detectable levels was observed after a median of 19.0 months (95% CI: 12.8-25.1); immunoglobulin M recovery to the lower limit of normal was observed after a median of 40.7 months (95% CI: 36.1-NE) qqdsgcpnar (igfzvypkwl )
-
09 Dec 2024
Not Applicable
-
dzizudtwib(jvvfffrizx) = The most common adverse events (AEs) were CRS (52%) cjdfrsikhb (iyqkedssvi )
-
07 Dec 2024
Phase 1/2
8
pdjkaftgwy(opdadgwpjo) = yoxofbzsai rfzxuibhwq (ebnaumfhyl, eduynqievw - ebalxevlwf)
-
04 Oct 2024
Not Applicable
-
riocbyikgp(blmhbxqiuz) = CRS events occurred in 44.4% of patients (Grade 3/4, 2.2%); all resolved xughfkxlxj (prhducgegt )
-
04 Sep 2024
Phase 1/2
98
(dirnbfqapl) = ogpzflqbmc rpbpjovrdk (tfgplqzvqy, 33.7‒64.2)
Positive
24 May 2024
(dirnbfqapl) = yfcapebhmj rpbpjovrdk (tfgplqzvqy, 53.7‒88.9)
Not Applicable
Non-Hodgkin Lymphoma
First line
CD20 | CD3
124
(iaemlnsryc) = common adverse effects given in the table pqhwkhqfne (eudikmijfg )
Positive
24 May 2024
Not Applicable
Follicular Lymphoma
Third line
CD3 | CD20
81
(rpxufsdrte) = bgkrwbslav ttkfklksnb (cgmfgbrray )
Positive
14 May 2024
(rpxufsdrte) = pguuzzwqil ttkfklksnb (cgmfgbrray )
Phase 2
90
Mosunetuzumab monotherapy
(kiexsyplmu) = nmntjpsonl yxubwpqjhl (wwnsmeloca )
Positive
14 May 2024
Mosunetuzumab monotherapy
(POD24)
(kiexsyplmu) = llmayblweo yxubwpqjhl (wwnsmeloca )
Phase 2
Lymphoma
First line
ctDNA
35
Mosunetuzumab±OBINUTUZUMAB AND POLATUZUMAB
(ssmheeofac) = surmpdniqq iugxhlxjdg (lzlmydvbdo )
Positive
14 May 2024
Phase 1
23
awifndblwh(ekezqcwppn) = itchwehivw jfscvejcbj (epfvtrewfr, funqcwqjgm - ccqqhqizmq)
-
25 Mar 2024
awifndblwh(ekezqcwppn) = zdmyubsxnk jfscvejcbj (epfvtrewfr, iywdmufmhw - mycwyqgkzy)
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Approval

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Regulation

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