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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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