CDEK
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polatuzumab vedotin

Trade name: Polivy

mAbapprovedADCOrphan Drug FDABreakthrough Therapy FDA

Approved

Jun 10, 2019

Polatuzumab vedotin, sold under the brand name Polivy, is an antibody-drug conjugate medication used for the treatment of diffuse large B-cell lymphoma (cancer). Polatuzumab is an antibody that targets CD79b, and vedotin is an agent that inhibits cell division by blocking the polymerisation of tubulin. — Wikipedia

Clinical trial activity

74 trials · 67 clinical orgs · 2 marketing orgs

Phase 1
21
Phase 2
62
Phase 3
8
Phase 4
0

Earliest trial started Oct 1, 2010 (NCT01209130)

Timeline

2010s

  1. Jan 1, 2010

    Genentech — Earliest Phase 1 Sponsor(trial)

  2. Dec 12, 2016

    Orphan Drug Designation

  3. Jan 1, 2017

    Roche — Earliest Phase 3 Sponsor(trial)

  4. Jun 10, 2019

    Roche — Earliest FDA Approval

  5. Jun 10, 2019

    Genentech — Marketing Organization

  6. Jun 10, 2019

    Roche — NDA Organization

2020s

  1. Jan 1, 2020

    Earliest Phase 2 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedBreakthroughJun 10, 2019

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No
Payload
Monomethylauristatin E

Oral

No

Parenteral

Yes

Topical

No

First in class

Sources

Also known as

  • acd22-vcmmae
  • acd79b-vcmmae
  • dcds-4501a
  • dcdt2980s
  • dcdt2980s
  • dcdt-2980s
  • fcu-2703
  • fcu-2711
  • pinatuzumab vedotin
  • pinatuzumab vedotin
  • pinatuzumab vedotin
  • polatuzumab vedotin
  • polatuzumab vedotin
  • polatuzumab vedotin
  • rg-7593
  • rg-7596
  • ro-5541072-000
  • ro-5541077-000

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07231250Phase 2Jan 15, 2026Sun Yat-Sen University
NCT07184788Phase 2Oct 1, 2025Government of China
NCT07122609Phase 2Aug 5, 2025Jiao Tong University
NCT07034508Phase 2Jun 20, 2025China Academy of Chinese Medical Sciences
NCT07012980Phase 2Jun 1, 2025BeOne Medicines, Fudan University, Roche
NCT07001540Phase 2May 8, 2025Fudan University, Fujian Medical University
NCT07078500Phase 2May 5, 2025Chinese Academy of Medical Sciences, Dongyang People's Hospital, Huzhou University, Nanchang University, Ningbo No. 5 Hospital, People's Hospital of Quzhou, Shaoxing Central Hospital, Shaoxing People's Hospital, The Central Hospital of Lishui City, Wenzhou Medical University, Yuyao People's Hospital of Zhejiang Province, Zhejiang University, Zhuji People's hospital
NCT06890884Phase 2Apr 11, 2025Merck
NCT06803693Phase 2Apr 1, 2025Jiao Tong University
NCT06730542Phase 1Mar 31, 2025BeOne Medicines, University of Miami
NCT06665217Phase 2Jan 31, 2025Government of China
NCT06765317Phase 2Jan 16, 2025Genentech, Memorial Sloan-Kettering Cancer Center
NCT06743945Phase 2Dec 31, 2024Fudan University
NCT06594939Phase 2Dec 31, 2024Medical College of Wisconsin
NCT06441097Phase 2Dec 31, 2024Jiao Tong University
NCT06664411Phase 2Dec 31, 2024Government of China
NCT06516978Phase 2Oct 1, 2024Nanjing Medical University
NCT06453044Phase 2Sep 9, 2024City of Hope National Medical Center, National Cancer Institute (NCI)
NCT06015880Phase 1Sep 3, 2024City of Hope National Medical Center, National Cancer Institute (NCI)
NCT06554600Phase 2Aug 31, 2024Zhejiang University
Showing 20 of 74 trials
Page 1 / 4

Organizations

Research & Development (67)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
RocheFor profit201342014
GenentechFor profit14422010
National Cancer Institute (NCI)Government8222020
Fudan UniversityAcademic/Hospital5512023
Jiao Tong UniversityAcademic/Hospital4422024
City of Hope National Medical CenterAcademic/Hospital3222020
Government of ChinaGovernment3312024
BeOne MedicinesFor profit2022025
Chinese Academy of Medical SciencesAcademic/Hospital2112023
Harvard UniversityAcademic/Hospital2212023
New York Medical CollegeAcademic/Hospital2212020
University of MiamiAcademic/Hospital2222023
University of WashingtonAcademic/Hospital2222020
Washington University in St. LouisAcademic/Hospital2212022
Zhejiang UniversityAcademic/Hospital2212024
AbbVieFor profit1112022
Academic and Community Cancer Research UnitedAcademic/Hospital1112020
ADC Therapeutics SARLFor profit1112021
Arbeitsgemeinschaft medikamentoese TumortherapieAcademic/Hospital1012023
Bristol-Myers SquibbFor profit1012021
67 organizations
Page 1 / 4

Marketing (2)

OrganizationOrg typeRelationshipDate
GenentechFor profitMKTGJun 10, 2019
RocheFor profitNDAJun 10, 2019