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Polatuzumab vedotin

Generic Name
Polatuzumab vedotin
Brand Names
Polivy
Drug Type
Biotech
Chemical Formula
-
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
Associated Therapies
-

A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Phase 1
Completed
Conditions
Relapsed or Refractory Follicular Lymphoma, Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Interventions
First Posted Date
2015-11-09
Last Posted Date
2023-12-26
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
114
Registration Number
NCT02600897
Locations
๐Ÿ‡ฌ๐Ÿ‡ง

Nottingham University Hospitals NHS Trust - City Hospital, Nottingham, United Kingdom

๐Ÿ‡ฌ๐Ÿ‡ง

Maidstone & Tonbridge Wells Hospital; Kent Oncology Center, Maidstone, United Kingdom

๐Ÿ‡ฌ๐Ÿ‡ง

Barking, Havering and Redbridge University Hospitals NHS Trust - Queen's Hospital, Romford, United Kingdom

and more 25 locations

A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma

First Posted Date
2013-11-25
Last Posted Date
2023-03-14
Lead Sponsor
Genentech, Inc.
Target Recruit Count
85
Registration Number
NCT01992653
Locations
๐Ÿ‡ซ๐Ÿ‡ท

Hopital Henri Mondor, Unite Hemopathies lymphoides, Creteil, France

๐Ÿ‡บ๐Ÿ‡ธ

Banner MD Anderson Cancer Center, Greeley, Colorado, United States

๐Ÿ‡บ๐Ÿ‡ธ

The University of Alabama at Birmingham, Birmingham, Alabama, United States

and more 8 locations

A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

Phase 1
Completed
Conditions
Follicular Lymphoma
Diffuse Large B-Cell Lymphoma
Interventions
First Posted Date
2012-09-25
Last Posted Date
2020-02-21
Lead Sponsor
Genentech, Inc.
Target Recruit Count
231
Registration Number
NCT01691898
Locations
๐Ÿ‡ฎ๐Ÿ‡น

Azienda Ospedale San Giovanni, Torino, Piemonte, Italy

๐Ÿ‡บ๐Ÿ‡ธ

Texas Oncology, P.A. - Tyler; Tyler Cancer Center, Tyler, Texas, United States

๐Ÿ‡จ๐Ÿ‡ฆ

McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology, Montreal, Quebec, Canada

and more 38 locations

A Study of Escalating Doses of Polatuzumab Vedotin in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma and Chronic Lymphocytic Leukemia and Polatuzumab Vedotin in Combination With Rituximab in Participants With Relapsed or Refractory B-Cell Non-Hodgkins Lymphoma

Phase 1
Completed
Conditions
Non-Hodgkins Lymphoma
Chronic Lymphocytic Leukemia
Interventions
First Posted Date
2011-02-07
Last Posted Date
2017-06-16
Lead Sponsor
Genentech, Inc.
Target Recruit Count
95
Registration Number
NCT01290549
Locations
๐Ÿ‡บ๐Ÿ‡ธ

M.D Anderson Cancer Center; Oncology, Houston, Texas, United States

๐Ÿ‡บ๐Ÿ‡ธ

Florida Cancer Specialists; Sarasota, Sarasota, Florida, United States

๐Ÿ‡ซ๐Ÿ‡ท

Centre Hospitalier Regional Universitaire de Lille, Lille, France

and more 13 locations
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