Polatuzumab vedotin (
INN; brand name Polivy, is an
antibody-drug conjugate or ADC designed for the treatment of cancer. The US
Food and Drug Administration approved polatuzumab vedotin in June 2019 for treatment of diffuse
large B-cell lymphoma when used in combination with
bendamustine and
rituximab after at least two prior therapies.
The drug was developed by
Genentech
Genentech, Inc., is an American biotechnology corporation headquartered in South San Francisco, California. It became an independent subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within R ...
(subsidiary of
Roche).
History
In June 2019, polatuzumab vedotin-piiq was approved in the United States in combination with the chemotherapy bendamustine and a rituximab product (a combination known as "BR"), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies.
Polatuzumab vedotin is a novel antibody-drug conjugate, and DLBCL is the most common type of non-Hodgkin lymphoma.
The U.S.
Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin used in combination with the chemotherapy bendamustine and a rituximab product.
Further clinical trials are required to verify and describe the clinical benefit of polatuzumab vedotin.
The FDA approved polatuzumab vedotin based primarily on evidence from one clinical trial (NCT02257567) that was conducted in the United States, Canada, Europe, and Asia.
Patients who participated in the trial had lymphoma that came back or did not improve after prior treatment.
The FDA granted the application of polatuzumab vedotin-piiq
breakthrough therapy designation,
priority review designation, and
orphan drug
An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases.
The assignment of ...
designation.
The FDA granted the approval of Polivy to Genentech.
Polatuzumab vedotin was approved for medical use in the European Union in January 2020 as a second-line treatment.
The
European Medicines Agency
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...
(EMA) designated polatuzumab vedotin an orphan medicine in April 2018.
In March 2022, the European Medicines Agency's
Committee for Medicinal Products for Human Use recommended Polatuzumab vedotin, in combination with R-CHP or
R-CHOP, as a primary treatment.
References
External links
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Breakthrough therapy
Genentech brands
Hoffmann-La Roche brands
Antibody-drug conjugates
Orphan drugs
Monoclonal antibodies for tumors
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