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

被引：2
|
作者：
Ali, Faraat [1 ]
Sharma, Kamna [2 ]
Ali, Asad [3 ]
机构：
[1] Botswana Med Regulatory Authority, Lab Serv, Plot 112,Int Finance Pk, Gaborone, Botswana
[2] Indo Soviet Friendship Coll Pharm, Dept Pharmaceut Anal, Moga, Punjab, India
[3] Jamia Hamdard, Sch Chem & Life Sci, Dept Chem, New Delhi, India
来源：
CURRENT DRUG TARGETS | 2022年 / 23卷 / 09期
关键词：
Pegfilgrastim-apgf (Nyvepria); biosimilar; febrile neutropenia; non-myeloid cancer; FDA; anticancer drugs; ONCOLOGY; SAFETY; CT-P6;
D O I：
10.2174/1389450123666220408101152
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
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).
引用
收藏
页码：924 / 932
页数：9
相关论文
共 50 条
  • [1] Budget Saving Potential of Pegfilgrastim Biosimilar for the Treatment of Chemotherapy-Induced Febrile Neutropenia, in Italy
    Berto, Patrizia
    Bellone, Marco
    Sabinot, Alice
    Pinto, Carmine
    Martino, Massimo
    Generali, Daniele
    Carriero, Pier Luigi
    Sanna, Maria Domenica
    FARMECONOMIA-HEALTH ECONOMICS AND THERAPEUTIC PATHWAYS, 2022, 23 (01) : 1 - 12
  • [2] RGB-02 (biosimilar pegfilgrastim) in the treatment of chemotherapy-induced neutropenia
    Santha, Dora
    Illes, Andras
    Aradi, Ildiko
    Horvat-Karajz, Karoly
    Kahan, Zsuzsanna
    FUTURE ONCOLOGY, 2019, 15 (18) : 2083 - 2092
  • [3] Risk of chemotherapy-induced febrile neutropenia with early discontinuation of pegfilgrastim prophylaxis in US clinical practice
    Weycker, Derek
    Li, Xiaoyan
    Barron, Rich
    Li, Yanli
    Reiner, Maureen
    Kartashov, Alex
    Figueredo, Jacqueline
    Tzivelekis, Spiros
    Garcia, Jacob
    SUPPORTIVE CARE IN CANCER, 2016, 24 (06) : 2481 - 2490
  • [4] Risk of chemotherapy-induced febrile neutropenia with early discontinuation of pegfilgrastim prophylaxis in US clinical practice
    Derek Weycker
    Xiaoyan Li
    Rich Barron
    Yanli Li
    Maureen Reiner
    Alex Kartashov
    Jacqueline Figueredo
    Spiros Tzivelekis
    Jacob Garcia
    Supportive Care in Cancer, 2016, 24 : 2481 - 2490
  • [5] Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim (the MONITOR-GCSF study)
    Pere Gascón
    Matti Aapro
    Heinz Ludwig
    Carsten Bokemeyer
    Mario Boccadoro
    Matthew Turner
    Kris Denhaerynck
    Karen MacDonald
    Ivo Abraham
    Supportive Care in Cancer, 2016, 24 : 911 - 925
  • [6] Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim (the MONITOR-GCSF study)
    Gascon, Pere
    Aapro, Matti
    Ludwig, Heinz
    Bokemeyer, Carsten
    Boccadoro, Mario
    Turner, Matthew
    Denhaerynck, Kris
    MacDonald, Karen
    Abraham, Ivo
    SUPPORTIVE CARE IN CANCER, 2016, 24 (02) : 911 - 925
  • [7] Empirical antimicrobial treatment for chemotherapy-induced febrile neutropenia
    Bal, Abhijit M.
    Gould, Ian M.
    INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS, 2007, 29 (05) : 501 - 509
  • [8] Risk of chemotherapy-induced febrile neutropenia by day of pegfilgrastim prophylaxis in US clinical practice from 2010 to 2015
    Weycker, Derek
    Bensink, Mark
    Lonshteyn, Alexander
    Doroff, Robin
    Chandler, David
    CURRENT MEDICAL RESEARCH AND OPINION, 2017, 33 (12) : 2107 - 2113
  • [9] Cost-efficiency analyses for the US of biosimilar filgrastim-sndz, reference filgrastim, pegfilgrastim, and pegfilgrastim with on-body injector in the prophylaxis of chemotherapy-induced (febrile) neutropenia
    McBride, Ali
    Campbell, Kim
    Bikkina, Mohan
    MacDonald, Karen
    Abraham, Ivo
    Balu, Sanjeev
    JOURNAL OF MEDICAL ECONOMICS, 2017, 20 (10) : 1083 - 1093
  • [10] Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia
    Cornelius F. Waller
    Gopinath M. Ranganna
    Eduardo J. Pennella
    Christopher Blakeley
    Miguel H. Bronchud
    Leonard A. Mattano Jr
    Oleksandr Berzoy
    Nataliia Voitko
    Yaroslav Shparyk
    Iryna Lytvyn
    Andriy Rusyn
    Vasil Popov
    István Láng
    Katrin Beckmann
    Rajiv Sharma
    Mark Baczkowski
    Mudgal Kothekar
    Abhijit Barve
    Annals of Hematology, 2019, 98 : 1217 - 1224
12345