 | |
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (frommouse) |
| 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 |
Polatuzumab vedotin, sold under the brand namePolivy, is anantibody-drug conjugate medication used for the treatment ofdiffuse large B-cell lymphoma (cancer).[6] Polatuzumab is anantibody that targetsCD79b, andvedotin is an agent that inhibits cell division by blocking the polymerisation oftubulin.
It was developed by theGenentech subsidiary ofRoche.[8]
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]
Polatuzumab vedotin isindicated in combination withbendamustine and arituximab 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]
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 USFood 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 vedotinbreakthrough therapy,priority review, andorphan 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] TheEuropean Medicines Agency (EMA) designated polatuzumab vedotin an orphan medicine in April 2018.[7] In March 2022, the European Medicines Agency'sCommittee for Medicinal Products for Human Use recommended Polatuzumab vedotin, in combination with R-CHP orR-CHOP, as a primary treatment.[12]
In February 2023, polatuzumab vedotin was recommended by theNational Institute for Health and Care Excellence (NICE) to be used in combination with rituximab,cyclophosphamide,doxorubicin andprednisolone (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 andprednisone 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 anInternational Prognostic Index score of two or greater.[14][15][16][17][18]
Polatuzumab vedotin is theinternational nonproprietary name[19][20] and theUnited States Adopted Name.[21]
This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain. This article incorporates text from this source, which is in thepublic domain.
