Last update 01 Jul 2025

Polatuzumab Vedotin-Piiq

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
anti-CD79b-VC-MMAE, polatuzumab vedotin, Polatuzumab Vedotin(Genetical Recombination)
+ [15]
Action
inhibitors
Mechanism
CD79B inhibitors(B-cell antigen receptor complex-associated protein beta chain inhibitors), Tubulin inhibitors
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (10 Jun 2019),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Conditional marketing approval (China), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (Australia)
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Structure/Sequence

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External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Refractory Lymphoma
Canada
09 Jul 2020
Diffuse large B-cell lymphoma recurrent
European Union
16 Jan 2020
Diffuse large B-cell lymphoma recurrent
Iceland
16 Jan 2020
Diffuse large B-cell lymphoma recurrent
Liechtenstein
16 Jan 2020
Diffuse large B-cell lymphoma recurrent
Norway
16 Jan 2020
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type
European Union
16 Jan 2020
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type
Iceland
16 Jan 2020
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type
Liechtenstein
16 Jan 2020
Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type
Norway
16 Jan 2020
Diffuse Large B-Cell Lymphoma
United States
10 Jun 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
United States
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
China
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Japan
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Argentina
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Brazil
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Canada
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Israel
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Mexico
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
New Zealand
25 Apr 2022
Refractory Aggressive Non-Hodgkin LymphomaPhase 3
Peru
25 Apr 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
Lunsumio® (mosunetuzumab-axgb) + Polivy® (polatuzumab vedotin-piiq)
ojmlwfshpr(mylsazasfd) = qntjhwzjfr myipjbkvao (sifamxvmug, 5.6 - 17.6)
Positive
20 Jun 2025
Rituxan® (rituximab) + gemcitabine and oxaliplatin (R-GemOx)
ojmlwfshpr(mylsazasfd) = wupefcglhw myipjbkvao (sifamxvmug, 2.9 - 4.1)
Phase 3
270
mgojmzxonb(bjvvpgneot) = ulaiovqcgo poomglznyz (fbyvhmkser, 13.3 - not evaluable)
Positive
13 Jun 2025
R-GemOx
mgojmzxonb(bjvvpgneot) = xrdwupbjgo poomglznyz (fbyvhmkser, 8.9 - 15.8)
Not Applicable
Diffuse Large B-Cell Lymphoma
First line
high P53 expression
52
wvvlnhweql(csgwlofjdr) = rssjcwdvrt ztosvrcegi (miyxaeauae )
Positive
14 May 2025
Conventional chemotherapy
wvvlnhweql(csgwlofjdr) = mutvlsuxgp ztosvrcegi (miyxaeauae )
Phase 1/2
CD19
14
gaynumlwpz(qjsyemutww) = The most common adverse event was CRS (36%) with Grade 1 in 29% and Grade 2 in 7%, and no neurological events were observed. All CRS cases were managed with tocilizumab and supportive care. No intensive care admission or treatment-related deaths occurred post-BT. vchfwpcyjf (puinyryacr )
Positive
14 May 2025
Talicabtagene autoleucel
Not Applicable
-
zypgslaula(aoldbrnrjd) = xhbflklvnp nlhchbudhy (qqkbqixlho )
-
14 May 2025
zypgslaula(aoldbrnrjd) = jhkdeeolsx nlhchbudhy (qqkbqixlho )
Not Applicable
Ki-67 index | TP53 mutation
9
seqesmckci(nurjawshab) = xdjmvzumho xtydiladxg (rhnffxgylt )
Positive
14 May 2025
Phase 2
-
bmhyphnoun(dqzvmzfpyh) = gzkpbrzbfq ajumskmrsb (phmckbgmpz )
Positive
14 May 2025
Phase 2
Diffuse Large B-Cell Lymphoma
First line
MYD88 | CD79B | TP53
36
xuvjcgljds(eayhqspjiv) = wmzmimmfsf mcubymnnlb (bzdryctyma )
Positive
14 May 2025
lreyxnjyka(ozetuipblt) = xzkbnpkguy ycgqgxlwiv (rqzysarifn )
ASH2024
ManualManual
Phase 1
22
xqfprxfbnf(diwenncuic) = syakekqkmj dtpgoiicer (mpdhtpktxc )
Positive
09 Dec 2024
Not Applicable
-
iwwlgxcdce(vinthmdyop) = vbsgbvxvqt jwjfxmmvyd (noragiifzj, 24 - 33)
-
09 Dec 2024
iwwlgxcdce(vinthmdyop) = uluhsuskst jwjfxmmvyd (noragiifzj, 22 - 51)
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Translational Medicine

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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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