Pegfilgrastim-Apgf (Nyvepria): Biosimilar USFDA Approval for the Treatment of Chemotherapy-induced Febrile Neutropenia and Current Updates on Clinical Trials
| Autor: | Faraat Ali, Kamna Sharma, Asad Ali |
|---|---|
| Rok vydání: | 2022 |
| Předmět: |
Pharmacology
Filgrastim United States Food and Drug Administration Antineoplastic Combined Chemotherapy Protocols Granulocyte Colony-Stimulating Factor Clinical Biochemistry Drug Discovery Humans Molecular Medicine Chemotherapy-Induced Febrile Neutropenia Biosimilar Pharmaceuticals United States Polyethylene Glycols |
| Zdroj: | Current Drug Targets. 23:924-932 |
| ISSN: | 1389-4501 |
| DOI: | 10.2174/1389450123666220408101152 |
| Popis: | 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 biosim-ilar 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 devel-opment of nyvepria foremost to approval for the treatment of febrile neutropenia (FN), a biosimilar regulatory framework, and current updates on the clinical trials (CTs). |
| Databáze: | OpenAIRE |
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