Fylnetra, a Biosimilar to Neulasta, Gets FDA Approval
The approval was based on data demonstrating a high degree of similarity of Fylnetra to the reference product, with no clinically meaningful differences.
White Blood Cell Disorders
FDA Accepts Resubmitted Eflapegrastim BLA for Chemotherapy-Induced Neutropenia
The BLA is supported by data from two phase 3 trials that evaluated eflapegrastim in early-stage breast cancer patients.
Biosimilar Releuko Gets FDA Approval
Approval was based on data demonstrating similarity between the 2 the biosimilar and reference product, Neupogen.
FDA Needs More Data on Plinabulin for Chemotherapy-Induced Neutropenia
Plinabulin is an investigational first-in-class selective immunomodulating microtubule-binding agent.
Manufacturing Deficiencies Delay Decision on Eflapegrastim
Eflapegrastim is a novel, long-acting G-CSF comprised of 2 protein components, an analogue of G-CSF and an Fc antibody fragment.
Neulasta Ad Claims Misleading, May Undermine Biosimilar Use, Says FDA
The ad claims that there is a higher risk of febrile neutropenia when pegfilgrastim is administered via prefilled syringe vs Neulasta Onpro on-body injector.
Ayvakit Approved for Advanced Systemic Mastocytosis
The approval was based on data from 2 multicenter, single-arm, open-label clinical trials that evaluated Ayvakit in 53 patients with advanced systemic mastocytosis.
Novel Biologic for Chemotherapy-Induced Neutropenia Submitted to FDA
Ryzneuta, also known as F-627, is an investigational, recombinant fusion protein containing G-CSF at the amino terminal and human IgG2-Fc fragment at the carboxyl terminal.
FDA Approves Nucala for Hypereosinophilic Syndrome
The FDA has approved Nucala (mepolizumab; GlaxoSmithKline) for the treatment of hypereosinophilic syndrome (HES) for 6 months or longer without another identifiable non-blood related cause of the disease in patients aged 12 years and older.
Biosimilar Nyvepria Gets FDA Approval
The Food and Drug Administration (FDA) has approved Nyvepria™ (pegfilgrastim-apgf; Pfizer), a biosimilar to Neulasta (pegfilgrastim; Amgen). Nyvepria, a leukocyte growth factor, is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. The approval…
