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 Clinical Study of Zilovertamab Vedotin (MK-2140) Plus Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Polatuzumab Vedotin Plus R-CHP in People With Diffuse Large B-cell Lymphoma (DLBCL) (MK-2140-011/waveLINE-011)
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Interventions
- First Posted Date
- 2025-03-24
- Last Posted Date
- 2025-05-06
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 594
- Registration Number
- NCT06890884
- Locations
- 🇮🇱
Haddasah Medical Center ( Site 0601), Jerusalem, Israel
🇮🇱Sheba Medical Center ( Site 0603), Ramat Gan, Israel
Efficacy and Safety of Pola-RCHP-X Vs Pola-RCHP in Untreated DLBCL
- Conditions
- Diffuse Large B-Cell Lymphoma
- Interventions
- First Posted Date
- 2025-01-31
- Last Posted Date
- 2025-01-31
- Lead Sponsor
- Ruijin Hospital
- Target Recruit Count
- 152
- Registration Number
- NCT06803693
Zanubrutinib in Combination With Pola-R-CHP and High-dose Methotrexate in Patients With Secondary CNS Lymphoma
- Conditions
- CNS Lymphoma
- Interventions
- First Posted Date
- 2024-12-12
- Last Posted Date
- 2025-05-08
- Lead Sponsor
- Juan P. Alderuccio, MD
- Target Recruit Count
- 20
- Registration Number
- NCT06730542
- Locations
- 🇺🇸
University of Miami, Miami, Florida, United States
Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma
- Conditions
- Diffuse Large B Cell Lymphoma (DLBCL)
- Interventions
- First Posted Date
- 2024-09-19
- Last Posted Date
- 2025-02-18
- Lead Sponsor
- Medical College of Wisconsin
- Target Recruit Count
- 31
- Registration Number
- NCT06594939
- Locations
- 🇺🇸
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
A Study of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma
- Conditions
- Refractory or Relapsed Diffuse Large B Cell Lymphoma
- Interventions
- First Posted Date
- 2024-08-15
- Last Posted Date
- 2024-08-15
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Target Recruit Count
- 36
- Registration Number
- NCT06554600
- Locations
- 🇨🇳
2nd Affiliated Hospital, School of Medicine, Zhejiang University, Hanzhou, Zhejiang, China
Polatuzumab, Rituximab and Orelabrutinib Combination Regimen (PRO) in the Treatment of Elderly Frail Patients with Treatment-naive Non-GCB DLBCL
- Conditions
- Diffuse Large B Cell Lymphoma
- Interventions
- First Posted Date
- 2024-07-31
- Last Posted Date
- 2025-02-04
- Lead Sponsor
- Affiliated Hospital of Nantong University
- Target Recruit Count
- 30
- Registration Number
- NCT06530511
- Locations
- 🇨🇳
Jiangsu Province Hospital, Nanjing, China
🇨🇳Affiliated hospital of Nantong University, Nantong, Jiangsu, China
A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL
- Conditions
- Diffuse Large B Cell Lymphoma
- Interventions
- First Posted Date
- 2024-07-24
- Last Posted Date
- 2024-07-24
- Target Recruit Count
- 528
- Registration Number
- NCT06516978
Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
- Conditions
- Safety IssuesEffects of Chemotherapy
- Interventions
- First Posted Date
- 2024-06-21
- Last Posted Date
- 2024-06-21
- Lead Sponsor
- The First Affiliated Hospital of Soochow University
- Target Recruit Count
- 20
- Registration Number
- NCT06468943
- Locations
- 🇨🇳
The First Affiliated Hospital of Soochow University, Suzhou, Nanjing, China
Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients With Relapsed or Refractory Grade 1-3a Follicular Lymphoma
- Conditions
- Refractory Grade 3a Follicular LymphomaRefractory Grade 1 Follicular LymphomaRefractory Grade 2 Follicular LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 3a Follicular LymphomaRecurrent Grade 2 Follicular Lymphoma
- Interventions
- Procedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyOther: Questionnaire Administration
- First Posted Date
- 2024-06-11
- Last Posted Date
- 2024-08-15
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 41
- Registration Number
- NCT06453044
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸City of Hope Orange County Lennar Foundation Cancer Center, Irvine, California, United States
Efficacy of Pola-RCHP-X vs Pola-RCHP in Untreated DLBCL
- Conditions
- Diffuse Large B-Cell Lymphoma
- Interventions
- First Posted Date
- 2024-06-04
- Last Posted Date
- 2024-06-04
- Lead Sponsor
- Ruijin Hospital
- Target Recruit Count
- 152
- Registration Number
- NCT06441097
Drug Development Updates
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