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By: News Feed | Last updated: 20th July 2018 | In: AE Management, Haematology, Oncology, US FDA Onc\Haem Approvals
Article Keywords
Amgen, AML, FDA, filgrastim, Neulasta, Pfizer
On July 20, the FDA approved filgrastim-aafi (Nivestym®, Pfizer), as a biosimilar to filgrastim (Neupogen, Amgen). The label includes all indications of the reference product.
Leading up to the FDA approval was a comprehensive data package demonstrating filgrastim-aafi has a high degree of similarity when compared to filgrastim.
Filgrastim-aafi is indicated by FDA label for:
- Reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukaemia (AML).
- Reduction of the duration of neutropenia and neutropenia-related clinical sequelae (e.g., febrile neutropenia) in patients with non-myeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation.
- Chronic administration to reduce the incidence and duration of sequelae of severe neutropenia (e.g., fever, infections, oropharyngeal ulcers) in symptomatic patients with congenital neutropenia, cyclic neutropenia, or idiopathic neutropenia.
Disclaimer
This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
© Copyright 2018 MediPaper Medical Communications Ltd.
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