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.
White Blood Cell Disorders
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…
Mepolizumab Gets Priority Review for Hypereosinophilic Syndrome
The FDA previously granted Fast Track and Orphan Drug designations to mepolizumab for the treatment of HES.
Ziextenzo, a Biosimilar to Neulasta, Receives FDA Approval
The FDA has approved Ziextenzo (pegfilgrastim-bmez; Sandoz), a biosimilar to Neulasta.
Long Acting IL-11 Analogue Granted Orphan Drug Status for Acute Radiation Syndrome
The FDA has granted BBT-059 (Bolder Technology) Orphan Drug designation for the treatment of acute radiation syndrome.
Investigational Treatment for Hypereosinophilic Syndrome Granted Orphan Drug Status
The Food and Drug Administration (FDA) has granted Orphan Drug designation to dexpramipexole (Knopp Biosciences), an investigational treatment for hypereosinophilic syndrome (HES). HES is characterized by peripheral eosinophilia with evidence of organ involvement. Treatment depends on the severity of the condition and underlying cause; while steroid therapy is effective in most patients, high doses are…
