Polatuzumab vedotin

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Polatuzumab vedotin
Monoclonal antibody
Type Whole antibody
Source Humanized (from mouse)
Target CD79B
Clinical data
Trade names Polivy
Other namesDCDS4501A, 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
  • none
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]

Contents

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

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

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

Names

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

Related Research Articles

Genentech, Inc. is an American biotechnology corporation headquartered in South San Francisco, California. It became an independent subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within Roche. Historically, the company is regarded as the world's first biotechnology company.

<span class="mw-page-title-main">Rituximab</span> Biopharmaceutical drug

Rituximab, sold under the brand name Rituxan among others, is a monoclonal antibody medication used to treat certain autoimmune diseases and types of cancer. It is used for non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, idiopathic thrombocytopenic purpura, pemphigus vulgaris, myasthenia gravis and Epstein–Barr virus-positive mucocutaneous ulcers. It is given by slow intravenous infusion. Biosimilars of Rituxan include Blitzima, Riabni, Ritemvia, Rituenza, Rixathon, Ruxience, and Truxima.

CHOP is the acronym for a chemotherapy regimen used in the treatment of non-Hodgkin lymphoma. CHOP consists of:

<span class="mw-page-title-main">Diffuse large B-cell lymphoma</span> Type of blood cancer

Diffuse large B-cell lymphoma (DLBCL) is a cancer of B cells, a type of lymphocyte that is responsible for producing antibodies. It is the most common form of non-Hodgkin lymphoma among adults, with an annual incidence of 7–8 cases per 100,000 people per year in the US and UK. This cancer occurs primarily in older individuals, with a median age of diagnosis at ~70 years, although it can occur in young adults and, in rare cases, children. DLBCL can arise in virtually any part of the body and, depending on various factors, is often a very aggressive malignancy. The first sign of this illness is typically the observation of a rapidly growing mass or tissue infiltration that is sometimes associated with systemic B symptoms, e.g. fever, weight loss, and night sweats.

Epratuzumab is a humanized monoclonal antibody. Potential uses may be found in oncology and in treatment of inflammatory autoimmune disorders, such as systemic lupus erythematosus (SLE).

<span class="mw-page-title-main">Mantle cell lymphoma</span> Type of blood cancer

Mantle cell lymphoma (MCL) is a type of non-Hodgkin's lymphoma, comprising about 6% of cases. It is named for the mantle zone of the lymph nodes where it develops. The term 'mantle cell lymphoma' was first adopted by Raffeld and Jaffe in 1991.

<span class="mw-page-title-main">Aggressive lymphoma</span> Medical condition

Aggressive lymphoma, also known as high-grade lymphoma, is a group of fast growing non-Hodgkin lymphoma.

<span class="mw-page-title-main">Bendamustine</span> Chemical compound

Bendamustine, sold under the brand name Treanda among others, is a chemotherapy medication used in the treatment of chronic lymphocytic leukemia (CLL), multiple myeloma, and non-Hodgkin's lymphoma. It is given by injection into a vein.

Obinutuzumab, sold under the brand name Gazyva among others, is a humanized anti-CD20 monoclonal antibody used as a treatment for cancer. It was originated by GlycArt Biotechnology AG and developed by Roche.

MorphoSys AG is a biopharmaceutical company founded in 1992. The company is headquartered near Munich, Germany and has a wholly owned subsidiary, MorphoSys US Inc., in Boston MA in the US. The company has various antibody, protein and peptide technologies that it uses to discover and develop both proprietary and partnered drug candidates. The company has more than 100 drugs in its wider pipeline that are being investigated for a variety of diseases. While many of these are being developed in partnership with pharma and biotech companies, MorphoSys also has a proprietary pipeline with a focus on cancer and autoimmune diseases.

Brentuximab vedotin, sold under the brand name Adcetris, is an antibody-drug conjugate medication used to treat relapsed or refractory Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (ALCL), a type of T cell non-Hodgkin lymphoma. It selectively targets tumor cells expressing the CD30 antigen, a defining marker of Hodgkin lymphoma and ALCL. The drug is being jointly marketed by Millennium Pharmaceuticals outside the US and by Seagen in the US.

<span class="mw-page-title-main">Ibrutinib</span> Medication used in cancer treatment

Ibrutinib, sold under the brand name Imbruvica among others, is a small molecule drug that inhibits B-cell proliferation and survival by irreversibly binding the protein Bruton's tyrosine kinase (BTK). Blocking BTK inhibits the B-cell receptor pathway, which is often aberrantly active in B cell cancers. Ibrutinib is therefore used to treat such cancers, including mantle cell lymphoma, chronic lymphocytic leukemia, and Waldenström's macroglobulinemia. Ibrutinib also binds to C-terminal Src Kinases. These are off-target receptors for the BTK inhibitor. Ibrutinib binds to these receptors and inhibits the kinase from promoting cell differentiation and growth. This leads to many different side effects like left atrial enlargement and atrial fibrillation during the treatment of Chronic Lymphocytic Leukemia.

Seagen Inc. is an American biotechnology company focused on developing and commercializing innovative, empowered monoclonal antibody-based therapies for the treatment of cancer. The company, headquartered in Bothell, Washington, is the industry leader in antibody-drug conjugates or ADCs, a technology designed to harness the targeting ability of monoclonal antibodies to deliver cell-killing agents directly to cancer cells. Antibody-drug conjugates are intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy, while potentially enhancing antitumor activity.

<span class="mw-page-title-main">Copanlisib</span> Chemical compound

Copanlisib, sold under the brand name Aliqopa, is a medication used for the treatment of adults experiencing relapsed follicular lymphoma who have received at least two prior systemic therapies.

<span class="mw-page-title-main">Venetoclax</span> Medication

Venetoclax, sold under the brand names Venclexta and Venclyxto, is a medication used to treat adults with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or acute myeloid leukemia (AML).

Tisagenlecleucel, sold under the brand name Kymriah, is a CAR T cells medication for the treatment of B-cell acute lymphoblastic leukemia (ALL) which uses the body's own T cells to fight cancer.

Lisocabtagene maraleucel, sold under the brand name Breyanzi, is a cell-based gene therapy used to treat large B-cell lymphoma.

<span class="mw-page-title-main">Selinexor</span> Anti-cancer drug

Selinexor sold under the brand name Xpovio among others, is a selective inhibitor of nuclear export used as an anti-cancer medication. It works by blocking the action of exportin 1 and thus blocking the transport of several proteins involved in cancer-cell growth from the cell nucleus to the cytoplasm, which ultimately arrests the cell cycle and leads to apoptosis. It is the first drug with this mechanism of action.

Primary testicular diffuse large B-cell lymphoma (PT-DLBCL), also termed testicular diffuse large B-cell lymphoma and diffuse large B-cell lymphoma of the testes, is a variant of the diffuse large B-cell lymphomas (DLBCL). DLBCL are a large and diverse group of B-cell malignancies with the great majority (-85%) being typed as diffuse large B-cell lymphoma, not otherwise specified. PT-DLBCL is a variant of DLBCL, NOS that involves one or, in uncommon cases, both testicles. Other variants and subtypes of DLBCL may involve the testes by spreading to them from their primary sites of origin in other tissues. PT-DLBCL differs from these other DLBCL in that it begins in the testes and then may spread to other sites.

Tafasitamab, sold under the brand name Monjuvi, is a medication used in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

References

  1. 1 2 3 "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. 1 2 https://www.guildlink.com.au/gc/ws/ro/pi.cfm?product=roppoliv11019 Archived 9 January 2023 at the Wayback Machine [ bare URL ]
  3. 1 2 "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. 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. 1 2 3 4 "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. 1 2 3 4 5 6 "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. 1 2 3 4 5 6 7 "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.PD-icon.svg 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. 1 2 3 "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.PD-icon.svg 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.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  15. ↑ "Roche's Polivy gets FDA OK in frontline lymphoma". pharmaphorum. 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)

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