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Review Article

Pegfilgrastim-Apgf (Nyvepria): Biosimilar USFDA Approval for the Treatment of Chemotherapy-induced Febrile Neutropenia and Current Updates on Clinical Trials

Author(s): Faraat Ali*, Kamna Sharma and Asad Ali

Volume 23, Issue 9, 2022

Published on: 13 May, 2022

Page: [924 - 932] Pages: 9

DOI: 10.2174/1389450123666220408101152

Price: $65

Abstract

Pegfilgrastim-apgf (nyvepria) was currently approved by FDA for the treatment of febrile neutropenia associated with non-myeloid malignancies receiving myelosuppressive anticancer drugs. It was developed by Pfizer, USA. It is a PEGylated leukocyte growth-stimulating factor indicated to reduce the incidence of febrile neutropenia in patients receiving anticancer drugs. Nyvepria is biosimilar to pegfilgrastim, approved by FDA on June 10, 2020. It is the fourth FDA-approved drug for the treatment of infection exhibiting febrile neutropenia. This review abridges the indicators in the development of nyvepria foremost to approval for the treatment of febrile neutropenia (FN), a biosimilar regulatory framework, and current updates on the clinical trials (CTs).

Keywords: Pegfilgrastim-apgf (Nyvepria), biosimilar, febrile neutropenia, non-myeloid cancer, FDA, anticancer drugs.

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[1]
Schellekens H, Smolen JS, Dicato M, Rifkin RM. Safety and efficacy of biosimilars in oncology. Lancet Oncol 2016; 17(11): e502-9.
[http://dx.doi.org/10.1016/S1470-2045(16)30374-6] [PMID: 27819248]
[2]
Weise M, Bielsky MC, De Smet K, et al. Biosimilars: What clinicians should know. Blood 2012; 120(26): 5111-7.
[http://dx.doi.org/10.1182/blood-2012-04-425744] [PMID: 23093622]
[3]
Nowicki M. Basic facts about biosimilars. Kidney Blood Press Res 2007; 30(5): 267-72.
[http://dx.doi.org/10.1159/000105133] [PMID: 17622764]
[4]
Lyman GH, Balaban E, Diaz M, et al. American society of clinical oncology statement: Biosimilars in oncology. J Clin Oncol 2018; 36(12): 1260-5.
[http://dx.doi.org/10.1200/JCO.2017.77.4893] [PMID: 29443651]
[5]
Calo-Fernández B, Martínez-Hurtado JL. Biosimilars: Company strategies to capture value from the biologics market. Pharmaceuticals (Basel) 2012; 5(12): 1393-408.
[http://dx.doi.org/10.3390/ph5121393] [PMID: 24281342]
[6]
Tsiftsoglou AS, Ruiz S, Schneider CK. Development and regulation of biosimilars: Current status and future challenges. BioDrugs 2013; 27(3): 203-11.
[http://dx.doi.org/10.1007/s40259-013-0020-y] [PMID: 23553340]
[7]
Zelenetz AD. Biosimilars in oncology. Oncol Hematol Rev 2016; 12(1): 22-8.
[http://dx.doi.org/10.17925/OHR.2016.12.01.22]
[8]
Nabhan C, Parsad S, Mato AR, Feinberg BA. Biosimilars in oncology in the united states: A review. JAMA Oncol 2018; 4(2): 241-7.
[http://dx.doi.org/10.1001/jamaoncol.2017.2004] [PMID: 28727871]
[9]
Camacho LH. Current status of biosimilars in oncology. Drugs 2017; 77(9): 985-97.
[http://dx.doi.org/10.1007/s40265-017-0743-z] [PMID: 28477160]
[10]
Roger SD. Biosimilars: Current status and future directions. Expert Opin Biol Ther 2010; 10(7): 1011-8.
[http://dx.doi.org/10.1517/14712591003796553] [PMID: 20384525]
[11]
Kresse GB. Biosimilars--science, status, and strategic perspective. Eur J Pharm Biopharm 2009; 72(3): 479-86.
[http://dx.doi.org/10.1016/j.ejpb.2009.02.014] [PMID: 19286455]
[12]
Dranitsaris G, Amir E, Dorward K. Biosimilars of biological drug therapies: Regulatory, clinical and commercial considerations. Drugs 2011; 71(12): 1527-36.
[http://dx.doi.org/10.2165/11593730-000000000-00000] [PMID: 21861538]
[13]
Rak Tkaczuk KH, Jacobs IA. Biosimilars in oncology: From development to clinical practice. Semin Oncol 2014; 41(2)(Suppl. 3): S3-S12.
[http://dx.doi.org/10.1053/j.seminoncol.2014.03.008] [PMID: 24767633]
[14]
Filgrastim. Drugbank online | database for drug and drug target info. Available from: https://go.drugbank.com/drugs/DB00099
[15]
Lenograstim. Drugbank online | database for drug and drug target info. Available from: https://go.drugbank.com/drugs/DB13144
[16]
Engert A, Griskevicius L, Zyuzgin Y, Lubenau H, del Giglio A. XM02, the first granulocyte colony-stimulating factor biosimilar, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with non-Hodgkin lymphoma receiving chemotherapy. Leuk Lymphoma 2009; 50(3): 374-9.
[http://dx.doi.org/10.1080/10428190902756081] [PMID: 19347726]
[17]
Gascón P, Aapro M, Ludwig H, et al. Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutro-penia with biosimilar filgrastim (the MONITOR-GCSF study). Support Care Cancer 2016; 24(2): 911-25.
[http://dx.doi.org/10.1007/s00520-015-2861-z] [PMID: 26306517]
[18]
Nyvepria (pegfilgrastim-apgf) FDA Approval History. 2020. Available from: https://www.drugs.com
[19]
First BiosimilarPegfilgrastim Gets FDA Approval. 2020. Available from: https://www.empr.com/home/news/first-biosimilar-pegfilgrastim-gets-fda-approval/
[20]
Biosimilar Development, Review, and Approval. Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-development-review-and-approval
[21]
Pegfilgrastim. Drugs.com Drugs.com | Prescription Drug Information, Interactions & Side effect Available from: https://www.drugs.com/medical-answers/cbqv-stand-3555530/
[22]
Aronson JK, Ferner RE. How similar are biosimilars? BMJ 2016; 353: i2721.
[http://dx.doi.org/10.1136/bmj.i2721] [PMID: 27188872]
[23]
Neulasta. Prescribing information. Amgen Inc. 2002. Available from: https://bit.ly/3phhB7Y (Accessed June 3, 2021).
[24]
Coherus Biosciences, Inc.. US FDA approves UDENYCA (pegfilgrastim-cbqv). News release. CoherusBioSciences, Inc. November 2. 2018. Available from: https://bit.ly/2Rxyt8c (Accessed June 3)
[25]
Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo (pegfilgrastim-bmez). 2021. Available from: https://bit.ly/2PP20Nh (Accessed 2021 June 3).
[26]
FDA approves Pfizer’s oncology supportive care biosimilar, Nyvepria (pegfilgrastim-apgf). 2021. Available from: https://bit.ly/3ceFxDw (Accessed 2021, June 3).
[27]
FDA approves Pfizer’s oncology supportive care biosimilar Nyvepria™ (Pegfilgrastim-apgf). 2020. Available from: https://investors.pfizer.com/investor-news/press-release-details/2020/FDA-Approves-Pfizers-Oncology-Supportive-Care-Biosimilar-NYVEPRIA-pegfilgrastim-apgf/default.aspx
[28]
Nyvepria (Pegfilgrastim-apgf Injection). Uses, Dosage, Side Effects, Interactions, Warning 2020. Available from https://www.rxlist.com/nyvepria-drug.htm#description
[29]
Bui LA, Hurst S, Finch GL, et al. Key considerations in the preclinical development of biosimilars. Drug Discov Today 2015; 20(Suppl. 1): 3-15.
[http://dx.doi.org/10.1016/j.drudis.2015.03.011] [PMID: 25912284]
[30]
Ali F, Sharma K, Anjum V, Ali A. Inebilizumab-cdon: USFDA approval for the treatment of NMOSD (neuromyelitis optica spectrum disorder). Curr Drug Discov Technol 2021 2022; 19(1): 22-8.
[http://dx.doi.org/10.2174/1570163818666210519103001] [PMID: 34011260]
[31]
Ali F, Ahmad J. Regulatory status of bioactive peptides bioactive peptides from food. Taylor & Francis Group 2022.
[http://dx.doi.org/10.1201/9781003106524-32]
[32]
Esteva FJ, Stebbing J, Wood-Horrall RN, Winkle PJ, Lee SY, Lee SJ. A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab. Cancer Chemother Pharmacol 2018; 81(3): 505-14.
[http://dx.doi.org/10.1007/s00280-017-3510-7] [PMID: 29330636]
[33]
Ratih R, Asmari M, Megied MA. Ahmed, Elbarbry F, Deeb SE. Biosimilars: Review of regulatory, manufacturing, analytical aspects and beyond. Microchem J 2021; 165: 106143.
[34]
Mishra P, Nayak B, Dey RK. PEGylation in anti-cancer therapy: An overview. Asian J Pharm Sci 2016; 11(11): 337-48.
[http://dx.doi.org/10.1016/j.ajps.2015.08.011]
[35]
Patel Krish, Howard MD. Febrile neutropenia. JAMA Oncol 2017; (12): 175.
[36]
FDA approves nyvepria, a biosimilar to neulasta for febrile neutropenia. 2020. Available from: https://www.curetoday.com/articles/fda-approves-nyvepria-a-biosimilar-to-neulasta-for-febrile-neutropenia
[37]
Aapro M, Boccia R, Leonard R, et al. Refining the role of pegfilgrastim (a long-acting G-CSF) for prevention of chemotherapy-induced febrile neutropenia: consensus guidance recommendations. Support Care Cancer 2017; 25(11): 3295-304.
[http://dx.doi.org/10.1007/s00520-017-3842-1] [PMID: 28842778]
[38]
NYVEPRIA™ (Pegfilgrastim-apgf) injection, for subcutaneous use Initial U.S. 2020. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761111lbl.pdf
[39]
Krendyukov A, Schiestl M. Biosimilars in oncology: A decade of experience with granulocyte colony stimulating factor and its implications for monoclonal antibodies. Crit Rev Oncol 2019; 23: 102785.
[40]
Stebbing J, Baranau Y, Baryash V, et al. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: A randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol 2017; 18(7): 917-28.
[http://dx.doi.org/10.1016/S1470-2045(17)30434-5] [PMID: 28592386]
[41]
Phillips MS. Pegfilgrastim. Clin J Oncol Nurs 2003; 7(2): 238-9.
[PMID: 12696226]
[42]
FDA Approves Nyvepria (Pegfilgrastim-apgf), a Biosimilar to Neulasta. 2020. Available from: https://www.drugs.com/newdrugs/fda-approves-nyvepria-pegfilgrastim-apgf-biosimilar-neulasta-5259.html
[43]
Nyvepria™ (Pegfilgrastim-apgf) new biosimilar approval. 2020. Available from: https://www.optumrx.com/
[44]
FDA Approves Peglgrastim-apgf, Biosimilar to Peglgrastim. Cancer Network. 2020. Available from: https://www.cancernetwork.com/view/fda-approves-pegfilgrastim-apgf-biosimilar-to-pegfilgrastim
[45]
Immunogenicity assessment of peg-filgrastim vs. Neulasta® as Adjunct to chemotherapy in patients with breast cancer 2020. NCT03511378, 2020.
[46]
Impact of pegfilgrastim on trastuzumab anti-tumor effect and ADCC in operable HER2+ breast cancer breast cancer 2020. NCT03571633, 2020.
[47]
Feasibility and cost analysis of pbsc mobilization using pegfilgrastim in hematologic malignancies. NCT00689884, 2020.
[48]
Pharmacokinetics and pharmacodynamics comparison study between two pegfilgrastim formulations. NCT02589301, 2020.
[49]
A comparative study on efficacy and safety of lipegfilgrastim in comparison to pegfilgrastim in elderly patients with aggressive B cell non-hodgkin lymphomas at high risk for R-CHOP-21-induced neutropenia. NCT02044276, 2020.
[50]
Patient preference for pegfilgrastim (Neulasta®) application forms 2020. NCT03619993, 2020.
[51]
Pegfilgrastim on day +3 compared to day +1 after salvage chemotherapy for patients with refractory or relapsed aggressive lymphoma. NCT02238873,
[52]
Assessing the immunogenicity of 2 subcutaneous doses of CHS-1701 (CoherusPegfilgrastim) with 2 subcutaneous doses neulasta. NCT02418104, 2020.
[53]
Pegfilgrastim-gema compared to pegfilgrastim-roche for prevention of induced neutropenia in breast cancer patients. NCT03404752, 2020.
[54]
SPI-2012 vs Pegfilgrastim in management of neutropenia in breast cancer patients with docetaxel and cyclophosphamide 2020. NCT02953340, 2020.
[55]
Pegfilgrastim administered on the same day as chemotherapy in non-hodgkin’s lymphoma. NCT00115193, 2020.
[56]
Pegfilgrastim as support to advanced breast cancer patients receiving chemotherapy. NCT00035594, 2020.

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