Polatuzumab vedotin
- Generic Name
- Polatuzumab vedotin
- Brand Names
- Polivy
- Drug Type
- Biotech
- CAS Number
- 1313206-42-6
- Unique Ingredient Identifier
- KG6VO684Z6
- Background
Polatuzumab vedotin is a CD79b-directed antibody-drug conjugate that delivers monomethyl auristatin E (MMAE), an anti-mitotic agent, to cancer cells. The drug consists of three components - a humanized immunoglobulin G1 (IgG1) monoclonal antibody specific for human CD79b (polatuzumab), MMAE, and protease-cleavable linker called maleimidocaproyl-valine-citrulline-p-aminobenzyloxycarbonyl (mc-vc-PAB) that covalently attaches MMAE to polatuzumab.
Polatuzumab vedotin was granted accelerated FDA approval on June 10, 2019 and was approved by Health Canada on July 9, 2020.
- Indication
Polatuzumab vedotin is used in combination with bendamustine and rituximab to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies. In Canada, this indication is approved for patients who are not eligible for autologous stem cell transplant and have received at least one prior therapy.
Polatuzumab vedotin is also used in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) to treat adult patients with previously untreated large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high-grade B-cell lymphoma, Epstein-Barr virus-positive (EBV+) DLBCL NOS, and T-cell/histiocyte rich LBCL.
- Associated Conditions
- Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Epstein-Barr Virus-positive Diffuse Large B-cell Lymphoma, High-grade B Cell Lymphoma (HGBCL), Large B Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, T-Cell/Histiocyte-Rich Large B-Cell Lymphoma, Relapsed Diffuse large B-cell lymphoma NOS
Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma
- Conditions
- Lymphoma, FollicularFollicular Lymphoma
- Interventions
- First Posted Date
- 2022-06-08
- Last Posted Date
- 2025-04-24
- Lead Sponsor
- Washington University School of Medicine
- Target Recruit Count
- 34
- Registration Number
- NCT05410418
- Locations
- 🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
- Conditions
- Non-Hodgkin Lymphoma
- Interventions
- First Posted Date
- 2022-03-17
- Last Posted Date
- 2025-03-04
- Lead Sponsor
- Genmab
- Target Recruit Count
- 394
- Registration Number
- NCT05283720
- Locations
- 🇪🇸
Hospital Universitario 12 de Octubre /ID# 243262, Madrid, Spain
🇭🇺Debreceni Egyetem-Klinikai Kozpont /ID# 242450, Debrecen, Hajdu-Bihar, Hungary
🇭🇺Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935, Kaposvár, Somogy, Hungary
A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
- Conditions
- Non-Hodgkin Lymphoma
- Interventions
- First Posted Date
- 2021-12-29
- Last Posted Date
- 2025-05-15
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 242
- Registration Number
- NCT05171647
- Locations
- 🇺🇸
City of Hope Cancer Center, Duarte, California, United States
🇺🇸St. Luke's Hospital, Chesterfield, Missouri, United States
🇺🇸Ascension Seton Infusion Center, Austin, Texas, United States
Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma
- Conditions
- Non-Hodgkin LymphomaGrade 1 Follicular LymphomaGrade 2 Follicular LymphomaGrade 3a Follicular LymphomaIndolent B-Cell Non-Hodgkin LymphomaMarginal Zone LymphomaRecurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid TissueRefractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
- Interventions
- Procedure: FDG-Positron Emission TomographyProcedure: Computed TomographyProcedure: Positron Emission TomographyProcedure: Bone Marrow BiopsyProcedure: Bone Marrow AspirationProcedure: Biospecimen Collection
- First Posted Date
- 2021-12-27
- Last Posted Date
- 2025-04-11
- Lead Sponsor
- University of Washington
- Target Recruit Count
- 42
- Registration Number
- NCT05169658
- Locations
- 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States
A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
- Conditions
- B-Cell Non-Hodgkin LymphomaRelapsed B-Cell Non-Hodgkin LymphomaRefractory B-Cell Non-Hodgkin Lymphoma
- Interventions
- First Posted Date
- 2021-07-21
- Last Posted Date
- 2025-05-22
- Lead Sponsor
- ADC Therapeutics S.A.
- Target Recruit Count
- 200
- Registration Number
- NCT04970901
- Locations
- 🇺🇸
Columbia University Irving Medical Center, New York, New York, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇨🇿Fakultni Nemocnice Brno, Brno, South Moravian, Czechia
A Multicentre, Parallel Arm, Open-label Trial of Frontline R-CHOP/Pola-RCHP and Glofitamab in Younger, Higher Risk Patients With Diffuse Large B Cell Lymphoma (DLBCL)
- Conditions
- Diffuse Large B Cell LymphomaHigh-grade B-cell Lymphoma
- Interventions
- First Posted Date
- 2021-06-07
- Last Posted Date
- 2024-08-12
- Lead Sponsor
- Peter MacCallum Cancer Centre, Australia
- Target Recruit Count
- 80
- Registration Number
- NCT04914741
- Locations
- 🇦🇺
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
🇦🇺St Vincent's Hospital Melbourne, Melbourne, Victoria, Australia
🇦🇺Alfred Hospital, Melbourne, Victoria, Australia
Study of PV in Combination With Bendamustine and Rituximab for Patients With R/R MCL
- Conditions
- Lymphoma, Mantle-Cell
- Interventions
- First Posted Date
- 2021-06-04
- Last Posted Date
- 2021-06-04
- Lead Sponsor
- Czech Lymphoma Study Group
- Target Recruit Count
- 21
- Registration Number
- NCT04913103
- Locations
- 🇨🇿
University Hospital Hradec Králové, Hradec Králové, Czechia
🇨🇿University Hospital Brno, Brno, Czechia
🇨🇿University Hospital Kralovske Vinohrady, Prague 10, Czechia
Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma
- Conditions
- Lymphoma, B-Cell
- Interventions
- First Posted Date
- 2021-05-12
- Last Posted Date
- 2025-03-24
- Lead Sponsor
- Celgene
- Target Recruit Count
- 174
- Registration Number
- NCT04884035
- Locations
- 🇬🇷
Local Institution - 703, Patras, Greece
🇨🇳Taichung Veterans General Hospital, Taichung City, Taiwan
🇺🇸Mayo Clinic - Arizona, Scottsdale, Arizona, United States
Study to Evaluate Tolerability of Iberdomide (CC-220) in Combination With Polatuzumab Vedotin Plus Rituximab or Tafasitamab or Rituximab Plus Chemotherapy in B-cell Lymphoma
- Conditions
- Lymphoma, B-Cell
- Interventions
- First Posted Date
- 2021-05-11
- Last Posted Date
- 2021-10-05
- Lead Sponsor
- Celgene
- Registration Number
- NCT04882163
- Locations
- 🇬🇧
Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom
🇺🇸Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Avera Cancer Institute, Sioux Falls, South Dakota, United States
Polatuzumab Vedotin Plus Rituximab, Ifosfamide, Carboplatin and Etoposide (Pola-R-ICE) Versus R-ICE Alone in Second Line Treatment of Diffuse Large B-cell Lymphoma (DLBCL)
- Conditions
- Relapsed Diffuse Large B-cell LymphomaRefractory Diffuse Large B-Cell Lymphoma
- Interventions
- First Posted Date
- 2021-04-06
- Last Posted Date
- 2025-02-18
- Lead Sponsor
- GWT-TUD GmbH
- Target Recruit Count
- 306
- Registration Number
- NCT04833114
- Locations
- 🇦🇹
UK Graz Universitätsklinik für Innere Medizin Klinische Abteilung für Hämatologie, Graz, Austria
🇦🇹LKH Hochsteiermark Standort Leoben Abteilung für Innere Medizin Department für Hämato-Onkologie, Leoben, Austria
🇦🇹Ordensklinikum Linz GmbH- Elisabethinen: I. Interne Abteilung Hämato-Onkologie, Linz, Austria
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.