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 |
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]
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 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]
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]
Polatuzumab vedotin is the international nonproprietary name [19] [20] and the United States Adopted Name. [21]
{{
cite web}}
: CS1 maint: archived copy as title (
link)
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 |
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]
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 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]
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]
Polatuzumab vedotin is the international nonproprietary name [19] [20] and the United States Adopted Name. [21]
{{
cite web}}
: CS1 maint: archived copy as title (
link)