|
Polatuzumab vedotin
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] Medical usesPolatuzumab 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] HistoryIn 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 cultureNamesPolatuzumab vedotin is the international nonproprietary name[19][20] and the United States Adopted Name.[21] References
Further reading
External links
|
||||||||||||||||||||||||||||||||||||||||||||||||||
