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Polatuzumab vedotin

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Polatuzumab vedotin
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetCD79B
Clinical data
Trade namesPolivy
Other namesDCDS4501A, RG7596, polatuzumab vedotin-piiq
AHFS/Drugs.comMonograph
MedlinePlusa619039
License data
Pregnancy
category
ATC code
Legal status
Legal status
Identifiers
CAS Number
IUPHAR/BPS
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6670H10317N1745O2087S40
Molar mass149627.43 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]

Medical uses

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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

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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

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Names

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Polatuzumab vedotin is the international nonproprietary name[19][20] and the United States Adopted Name.[21]

References

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  1. ^ a b c "Polivy Australian prescription medicine decision summary". Therapeutic Goods Administration (TGA). 13 December 2019. Archived from the original on 5 March 2020. Retrieved 23 August 2020.
  2. ^ a b "AUSTRALIAN PRODUCT INFORMATION – POLIVY (polatuzumab vedotin)". Archived from the original on 12 July 2024. Retrieved 12 July 2024.
  3. ^ a b "Summary Basis of Decision (SBD) for Polivy". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
  4. ^ "Polivy 30 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC)". (emc). 20 July 2022. Archived from the original on 22 April 2023. Retrieved 22 April 2023.
  5. ^ "Polivy 140 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC)". (emc). 20 July 2022. Archived from the original on 12 July 2024. Retrieved 22 April 2023.
  6. ^ a b c d "Polivy- polatuzumab vedotin injection, powder, lyophilized, for solution". DailyMed. 14 November 2019. Archived from the original on 22 October 2020. Retrieved 23 August 2020.
  7. ^ a b c d e f "Polivy EPAR". European Medicines Agency (EMA). 27 January 2020. Archived from the original on 27 October 2020. Retrieved 8 March 2020.
  8. ^ "FDA Grants Genentech's Polivy Accelerated Approval for People With Previously Treated Aggressive Lymphoma" (Press release). Genentech. 10 June 2019. Archived from the original on 17 February 2023. Retrieved 22 April 2023.
  9. ^ a b c d e f g "FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma" (Press release). U.S. Food and Drug Administration (FDA). 10 June 2019. Archived from the original on 25 November 2019. Retrieved 24 November 2019.Public Domain This article incorporates text from this source, which is in the public domain.
  10. ^ "Drug Approval Package: Polivy". U.S. Food and Drug Administration (FDA). 2 July 2019. Archived from the original on 30 October 2020. Retrieved 8 March 2020.
  11. ^ a b c "Drug Trials Snapshots: Polivy". U.S. Food and Drug Administration (FDA). 17 June 2019. Archived from the original on 25 November 2019. Retrieved 24 November 2019.Public Domain This article incorporates text from this source, which is in the public domain.
  12. ^ "Polatuzumab Vedotin Plus R-CHP Recommended for EU Approval for Previously Untreated DLBCL". OneLive. 25 March 2022. Archived from the original on 19 April 2023. Retrieved 8 July 2022.
  13. ^ "Roche's Polivy recommended by NICE for lymphoma therapy". PMLive. 2 February 2023. Archived from the original on 9 February 2023. Retrieved 9 February 2023.
  14. ^ "FDA approves polatuzumab vedotin-piiq for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma". U.S. Food and Drug Administration (FDA). 19 April 2023. Archived from the original on 21 April 2023. Retrieved 21 April 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  15. ^ "Roche's Polivy gets FDA OK in frontline lymphoma". pharmaphorum. 20 April 2023. Archived from the original on 22 April 2023. Retrieved 20 April 2023.
  16. ^ Vinluan, Frank (19 April 2023). "New FDA Nod for Roche Drug Moves It to the Front Line in Treating Blood Cancer". MedCity News. Archived from the original on 22 April 2023. Retrieved 20 April 2023.
  17. ^ "FDA Approves Genentech's Polivy in Combination With R-CHP for People With Certain Types of Previously Untreated Diffuse Large B-Cell Lymphoma" (Press release). Genentech. 19 April 2023. Archived from the original on 19 April 2023. Retrieved 22 April 2023.
  18. ^ "Polivy". Genentech. Archived from the original on 15 April 2023. Retrieved 15 July 2022.
  19. ^ World Health Organization (2013). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 70". WHO Drug Information. 27 (3). hdl:10665/331167.
  20. ^ World Health Organization (2014). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 71". WHO Drug Information. 28 (1). hdl:10665/331151.
  21. ^ "Archived copy" (PDF). Archived (PDF) from the original on 22 April 2023. Retrieved 22 April 2023.{{cite web}}: CS1 maint: archived copy as title (link)

Further reading

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  • Clinical trial number NCT02257567 for "A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma" at ClinicalTrials.gov
  • Clinical trial number NCT03274492 for "A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma (POLARIX)" at ClinicalTrials.gov
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