|Source||Humanized (from mouse)|
|Other names||DCDS4501A, RG7596, polatuzumab vedotin-piiq|
|Drug class||Antibody-drug conjugate|
|Main uses||Diffuse large B-cell lymphoma|
|Side effects||Low red blood cells, low platelets, low white blood cells, diarrhea, nausea, fever|
|Typical dose||1.8 mg/kg|
|US NLM||Polatuzumab vedotin|
|Chemical and physical data|
|Molar mass||149627.43 g·mol−1|
Polatuzumab vedotin, sold under the brand name Polivy, is a medication used to treat diffuse large B-cell lymphoma in combination with bendamustine and rituximab. It is used when other treatments have not worked. It is given by gradual injection into a vein.
Common side effects include low red blood cells, low platelets, low white blood cells, diarrhea, nausea, and fever. Other side effects may include peripheral neuropathy, infusion reaction, tumor lysis syndrome, liver problems, and infection. Use in pregnancy may harm the baby. It is a monoclonal antibody joined with monomethyl auristatin E (MMAE) that attaches to CD79b.
Polatuzumab vedotin was approved for medical use in the United States in 2019 and Europe in 2020. In the United Kingdom 140 mg costs the NHS about £11,000 as of 2021. This amount in the United States costs about 15,700 USD.
It is given as a dose of 1.8 mg/kg every 21 days for a total of six doses.
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 designation. The FDA granted the approval of Polivy to Genentech.
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