U.S. License Holder:
Pfizer Inc.
Date of License:
July-20-2018
Last Update:
Nov-15-2024
FDA-Approved Indications
NIVESTYM (filgrastim-aafi) is a leukocyte growth factor indicated to:
Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever;
Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML);
Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT);
Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis;
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.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Nivestym® (Pfizer) (April-2020)
Biosimilars Approved In The E.U.
Nivestim® (Hospira) (June-2010)
Biosimilars Approved In Australia
Nivestim® (Pfizer) (September-2010)
Inter Partes Review Proceedings
U.S. Patent Litigations
