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
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