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Wikipedia

Polatuzumab vedotin

May 01, 2024

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]

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
  • 1313206-42-6
IUPHAR/BPS
  • 8404
DrugBank
  • DB12240
ChemSpider
  • none
UNII
  • KG6VO684Z6
KEGG
  • D10761
Chemical and physical data
FormulaC6670H10317N1745O2087S40
Molar mass149627.43 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 edit

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 edit

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 edit

Names edit

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

References edit

  1. ^ a b c "Polivy Australian prescription medicine decision summary". Therapeutic Goods Administration (TGA). 13 December 2019. from the original on 5 March 2020. Retrieved 23 August 2020.
  2. ^ a b https://www.guildlink.com.au/gc/ws/ro/pi.cfm?product=roppoliv11019 9 January 2023 at the Wayback Machine [bare URL]
  3. ^ a b "Summary Basis of Decision (SBD) for Polivy". Health Canada. 23 October 2014. 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. Retrieved 22 April 2023.
  5. ^ "Polivy 140 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC)". (emc). 20 July 2022. Retrieved 22 April 2023.
  6. ^ a b c d "Polivy- polatuzumab vedotin injection, powder, lyophilized, for solution". DailyMed. 14 November 2019. 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. 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. 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. from the original on 25 November 2019. Retrieved 24 November 2019.  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. 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. from the original on 25 November 2019. Retrieved 24 November 2019.  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. 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. 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. from the original on 21 April 2023. Retrieved 21 April 2023.   This article incorporates text from this source, which is in the public domain.
  15. ^ "Roche's Polivy gets FDA OK in frontline lymphoma". pharmaphorum. 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. 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. from the original on 19 April 2023. Retrieved 22 April 2023.
  18. ^ "Polivy". Genentech. 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). (PDF) from the original on 22 April 2023. Retrieved 22 April 2023.{{cite web}}: CS1 maint: archived copy as title (link)

Further reading edit

  • Bourbon E, Salles G (October 2020). "Polatuzumab vedotin: an investigational anti-CD79b antibody drug conjugate for the treatment of diffuse large B-cell lymphoma". Expert Opinion on Investigational Drugs. 29 (10): 1079–1088. doi:10.1080/13543784.2020.1800638. PMID 32700972. S2CID 220718129.
  • Burke JM, Morschhauser F, Andorsky D, Lee C, Sharman JP (October 2020). "Antibody-drug conjugates for previously treated aggressive lymphomas: focus on polatuzumab vedotin". Expert Review of Clinical Pharmacology. 13 (10): 1073–1083. doi:10.1080/17512433.2020.1826303. PMID 32985934.
  • Deeks ED (September 2019). "Polatuzumab Vedotin: First Global Approval". Drugs. 79 (13): 1467–1475. doi:10.1007/s40265-019-01175-0. PMC 6794237. PMID 31352604.
  • Tilly H, Morschhauser F, Sehn LH, Friedberg JW, Trněný M, Sharman JP, et al. (January 2022). "Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma". The New England Journal of Medicine. 386 (4): 351–363. doi:10.1056/NEJMoa2115304. PMID 34904799.

External links edit

  • 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

May 01, 2024
polatuzumab, vedotin, sold, under, brand, name, polivy, cd79b, directed, antibody, drug, conjugate, medication, used, treatment, diffuse, large, cell, lymphoma, cancer, developed, genentech, subsidiary, roche, monoclonal, antibodytypewhole, antibodysourcehuman. 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 Polatuzumab vedotinMonoclonal antibodyTypeWhole antibodySourceHumanized from mouse TargetCD79BClinical dataTrade namesPolivyOther namesDCDS4501A RG7596 polatuzumab vedotin piiqAHFS Drugs comMonographMedlinePlusa619039License dataEU EMA by INN US DailyMed Polatuzumab vedotin US FDA PolivyPregnancycategoryAU D 1 2 ATC codeL01FX14 WHO Legal statusLegal statusAU S4 Prescription only 1 2 CA only Schedule D 3 UK POM Prescription only 4 5 US only 6 EU Rx only 7 In general Prescription only IdentifiersCAS Number1313206 42 6IUPHAR BPS8404DrugBankDB12240ChemSpidernoneUNIIKG6VO684Z6KEGGD10761Chemical and physical dataFormulaC 6670H 10317N 1745O 2087S 40Molar mass149627 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 Contents 1 Medical uses 2 History 3 Society and culture 3 1 Names 4 References 5 Further reading 6 External linksMedical uses editPolatuzumab 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 editIn 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 editNames edit Polatuzumab vedotin is the international nonproprietary name 19 20 and the United States Adopted Name 21 References edit 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 a b https www guildlink com au gc ws ro pi cfm product roppoliv11019 Archived 9 January 2023 at the Wayback Machine bare URL 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 Polivy 30 mg powder for concentrate for solution for infusion Summary of Product Characteristics SmPC emc 20 July 2022 Retrieved 22 April 2023 Polivy 140 mg powder for concentrate for solution for infusion Summary of Product Characteristics SmPC emc 20 July 2022 Retrieved 22 April 2023 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 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 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 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 nbsp This article incorporates text from this source which is in the public domain 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 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 nbsp This article incorporates text from this source which is in the public domain 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 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 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 nbsp This article incorporates text from this source which is in the public domain Roche s Polivy gets FDA OK in frontline lymphoma pharmaphorum Archived from the original on 22 April 2023 Retrieved 20 April 2023 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 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 Polivy Genentech Archived from the original on 15 April 2023 Retrieved 15 July 2022 World Health Organization 2013 International nonproprietary names for pharmaceutical substances INN recommended INN list 70 WHO Drug Information 27 3 hdl 10665 331167 World Health Organization 2014 International nonproprietary names for pharmaceutical substances INN recommended INN list 71 WHO Drug Information 28 1 hdl 10665 331151 Archived copy PDF Archived PDF from the original on 22 April 2023 Retrieved 22 April 2023 a href Template Cite web html title Template Cite web cite web a CS1 maint archived copy as title link Further reading editBourbon E Salles G October 2020 Polatuzumab vedotin an investigational anti CD79b antibody drug conjugate for the treatment of diffuse large B cell lymphoma Expert Opinion on Investigational Drugs 29 10 1079 1088 doi 10 1080 13543784 2020 1800638 PMID 32700972 S2CID 220718129 Burke JM Morschhauser F Andorsky D Lee C Sharman JP October 2020 Antibody drug conjugates for previously treated aggressive lymphomas focus on polatuzumab vedotin Expert Review of Clinical Pharmacology 13 10 1073 1083 doi 10 1080 17512433 2020 1826303 PMID 32985934 Deeks ED September 2019 Polatuzumab Vedotin First Global Approval Drugs 79 13 1467 1475 doi 10 1007 s40265 019 01175 0 PMC 6794237 PMID 31352604 Tilly H Morschhauser F Sehn LH Friedberg JW Trneny M Sharman JP et al January 2022 Polatuzumab Vedotin in Previously Untreated Diffuse Large B Cell Lymphoma The New England Journal of Medicine 386 4 351 363 doi 10 1056 NEJMoa2115304 PMID 34904799 External links editClinical 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 Portal nbsp Medicine Retrieved from https en wikipedia org w index php title Polatuzumab vedotin amp oldid 1190946031, wikipedia, wiki, book, books, library,

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