Polatuzumab vedotin (

INN Inns are generally establishments or buildings where travelers can seek lodging, and usually, food and drink. Inns are typically located in the country or along a highway; before the advent of motorized transportation they also provided accommo ...

; brand name Polivy, is an

antibody-drug conjugate Antibody-drug conjugates or ADCs are a class of biopharmaceutical drugs designed as a targeted therapy for treating cancer. Unlike chemotherapy, ADCs are intended to target and kill tumor cells while sparing healthy cells. As of 2019, some 56 phar ...

or ADC designed for the treatment of cancer. The US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

approved polatuzumab vedotin in June 2019 for treatment of diffuse

large B-cell lymphoma The large-cell lymphomas have large cells. One classification system for lymphomas divides the diseases according to the size of the white blood cells that have turned cancerous. A large cell, in this context, has a diameter of 17 to 20 μm. ...

when used in combination with

bendamustine Bendamustine, sold under the brand name Treanda among others, is a chemotherapy medication used in the treatment of chronic lymphocytic leukemia (CLL), multiple myeloma, and non-Hodgkin's lymphoma. It is given by injection into a vein. Common ...

and

rituximab Rituximab, sold under the brand name Rituxan among others, is a monoclonal antibody medication used to treat certain autoimmune diseases and types of cancer. It is used for non-Hodgkin lymphoma, chronic lymphocytic leukemia (in non-geriatric pa ...

after at least two prior therapies. The drug was developed by Genentech (subsidiary of

Roche F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX ...

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.

(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 Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act. The FDA's "br ...

designation,

priority review Priority review is a program of the United States Food and Drug Administration (FDA) to expedite the review process for drugs that are expected to have a particularly great impact on the treatment of a disease. The priority review voucher program ...

designation, and orphan drug 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 (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 The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regardin ...

recommended Polatuzumab vedotin, in combination with R-CHP or R-CHOP, as a primary treatment.

References

External links

* * Breakthrough therapy Genentech brands Hoffmann-La Roche brands Antibody-drug conjugates Orphan drugs Monoclonal antibodies for tumors {{antineoplastic-drug-stub