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
A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Participants With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma (DLBCL)
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Interventions
- First Posted Date
- 2021-03-10
- Last Posted Date
- 2024-07-11
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 50
- Registration Number
- NCT04790903
- Locations
- 🇫🇷
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez, Lille, France
🇫🇷CHU Montpellier - Saint ELOI, Montpellier, France
🇺🇸Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation
- Conditions
- Chronic Lymphocytic LeukemiaRichter Syndrome
- Interventions
- First Posted Date
- 2020-12-22
- Last Posted Date
- 2024-10-31
- Lead Sponsor
- Weill Medical College of Cornell University
- Target Recruit Count
- 20
- Registration Number
- NCT04679012
- Locations
- 🇺🇸
Weill Cornell Medicine, New York, New York, United States
🇺🇸Mount Sinai- Icahn School of Medicine, New York, New York, United States
🇺🇸Columbia University Medical Center, New York, New York, United States
Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- Conditions
- Diffuse Large B-Cell Lymphoma UnclassifiableRecurrent Diffuse Large B-Cell LymphomaRefractory Primary Mediastinal (Thymic) Large B-Cell Cell LymphomaRecurrent Primary Mediastinal (Thymic) Large B-Cell Cell LymphomaRecurrent Transformed B-Cell Non-Hodgkin LymphomaRefractory Transformed B-Cell Non-Hodgkin LymphomaRefractory Diffuse Large B-Cell Lymphoma
- Interventions
- First Posted Date
- 2020-12-14
- Last Posted Date
- 2025-02-17
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 41
- Registration Number
- NCT04665765
- Locations
- 🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸City of Hope Medical Center, Duarte, California, United States
Polatuzumab Vedotin, Venetoclax, and Rituximab and Hyaluronidase Human for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
- Conditions
- Recurrent Grade 3a Follicular LymphomaRecurrent B-Cell Non-Hodgkin LymphomaRefractory B-Cell Non-Hodgkin LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Marginal Zone LymphomaRefractory Grade 1 Follicular LymphomaRefractory Mantle Cell LymphomaRecurrent Grade 1 Follicular LymphomaRefractory Small Lymphocytic LymphomaRecurrent Mantle Cell Lymphoma
- Interventions
- First Posted Date
- 2020-12-09
- Last Posted Date
- 2024-01-08
- Lead Sponsor
- Academic and Community Cancer Research United
- Target Recruit Count
- 63
- Registration Number
- NCT04659044
- Locations
- 🇺🇸
Siouxland Regional Cancer Center, Sioux City, Iowa, United States
🇺🇸Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States
🇺🇸Laura and Isaac Perlmutter Cancer Center at NYU Langone, New York, New York, United States
A Multicenter, Retrospective Observational Study to Evaluate the Effectiveness and Safety of Polatuzumab Vedotin
- Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
- Interventions
- First Posted Date
- 2020-11-12
- Last Posted Date
- 2020-11-12
- Lead Sponsor
- Jiangsu Cancer Institute & Hospital
- Target Recruit Count
- 35
- Registration Number
- NCT04624893
- Locations
- 🇨🇳
Jiangsu Cancer Hospital, Nanjing, Jiangsu, China
Study of Selinexor in Combination With Backbone Treatments or Novel Therapies In Participants With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL)
- Conditions
- Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- Interventions
- First Posted Date
- 2020-10-29
- Last Posted Date
- 2023-01-25
- Lead Sponsor
- Karyopharm Therapeutics Inc
- Target Recruit Count
- 350
- Registration Number
- NCT04607772
- Locations
- 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
🇺🇸US Oncology - Oncology Associates of Oregon, Eugene, Oregon, United States
🇺🇸University of Texas Southwestern, Dallas, Texas, United States
A Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients with DLBCL
- Conditions
- Lymphoma, B-CellDLBCL
- Interventions
- First Posted Date
- 2020-10-20
- Last Posted Date
- 2024-11-05
- Lead Sponsor
- University of Rochester
- Target Recruit Count
- 39
- Registration Number
- NCT04594798
- Locations
- 🇺🇸
University of Rochester, Rochester, New York, United States
POLA+BR for Relapsed or Refractory DLBCL
- First Posted Date
- 2020-09-01
- Last Posted Date
- 2022-05-09
- Lead Sponsor
- University of Colorado, Denver
- Registration Number
- NCT04535102
Autologous Stem Cell Transplant Followed by Polatuzumab Vedotin in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma
- Conditions
- B-cell LymphomaDiffuse Large B Cell LymphomaTransformed Non-Hodgkin LymphomaBurkitt LymphomaFollicular LymphomaMantle Cell LymphomaMarginal Zone LymphomaRichter SyndromeHodgkin Lymphoma
- Interventions
- First Posted Date
- 2020-07-29
- Last Posted Date
- 2023-10-26
- Lead Sponsor
- New York Medical College
- Target Recruit Count
- 20
- Registration Number
- NCT04491370
- Locations
- 🇺🇸
New York Medical Center, Valhalla, New York, United States
Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma
- Conditions
- Diffuse Large B-Cell LymphomaHigh Grade B-Cell Lymphoma w/MYC & BCL2 or BCL6 RearrangementsHigh Grade B-Cell Lymphoma w/MYC, BCL2 & BCL6 RearrangementsDouble Expressor LymphomaHigh-grade B-cell Lymphoma
- Interventions
- First Posted Date
- 2020-07-21
- Last Posted Date
- 2025-05-02
- Lead Sponsor
- Barbara Ann Karmanos Cancer Institute
- Target Recruit Count
- 8
- Registration Number
- NCT04479267
- Locations
- 🇺🇸
Karmanos Cancer Institute, Detroit, Michigan, United States
Drug Development Updates
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