Polatuzumab vedotin
Pharmaceutical drug From Wikipedia, the free encyclopedia
Polatuzumab vedotin, sold under the brand name Polivy, is a CD79b-directed antibody-drug conjugate medication used for the treatment of diffuse large B-cell lymphoma (cancer).[6] It was developed by the Genentech subsidiary of Roche.[8]
 | |
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | CD79B |
| Clinical data | |
| Trade names | Polivy |
| Other names | DCDS4501A, RG7596, polatuzumab vedotin-piiq |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a619039 |
| License data |
|
| Pregnancy category | |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| IUPHAR/BPS | |
| DrugBank | |
| ChemSpider |
|
| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6670H10317N1745O2087S40 |
| Molar mass | 149627.43 g·mol−1 |
The most common side effects include low levels of white blood cells (neutropenia), platelets (thrombocytopenia) and red blood cells (anemia); nerve damage (peripheral neuropathy); fatigue; diarrhea; fever; decreased appetite; and pneumonia.[9]
Polatuzumab vedotin was approved for medical use in the United States in June 2019,[9][10][11] in Australia in October 2019,[1] in the European Union in January 2020,[7] and in Canada in November 2020.[3]
Medical uses
Polatuzumab vedotin is indicated in combination with bendamustine and a rituximab product for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma.[6][7]
Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adults with previously untreated diffuse large B-cell lymphoma (DLBCL).[6][7]
History
Summarize
Perspective
In June 2019, polatuzumab vedotin was approved in the United States in combination with the chemotherapy bendamustine and a rituximab product, to treat adults with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies.[9] Polatuzumab vedotin is a novel antibody-drug conjugate, and DLBCL is the most common type of non-Hodgkin lymphoma.[9] The US Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin used in combination with the chemotherapy bendamustine and a rituximab product.[9]
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.[11] Participants in the trial had lymphoma that came back or did not improve after prior treatment.[11] The FDA granted the application of polatuzumab vedotin breakthrough therapy, priority review, and orphan drug designations.[9] The FDA granted the approval of Polivy to Genentech.[9]
Polatuzumab vedotin was approved for medical use in the European Union in January 2020, as a second-line treatment.[7] The European Medicines Agency (EMA) designated polatuzumab vedotin an orphan medicine in April 2018.[7] 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.[12]
In February 2023, polatuzumab vedotin was recommended by the National Institute for Health and Care Excellence (NICE) to be used in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) for untreated diffuse large B-cell lymphoma (DLBCL).[13]
In April 2023, the FDA approved polatuzumab vedotin in combination with rituximab, cyclophosphamide, doxorubicin and prednisone as first-line therapy for people with previously untreated diffuse large B-cell lymphoma, not otherwise specified or high-grade B-cell lymphoma who have an International Prognostic Index score of two or greater.[14][15][16][17][18]
Society and culture
Names
Polatuzumab vedotin is the international nonproprietary name[19][20] and the United States Adopted Name.[21]
References
Further reading
External links
Wikiwand - on
Seamless Wikipedia browsing. On steroids.