On June 11, the U.S. Food and Drug Administration (FDA) approved a biosimilar to pegfilgrastim (Neulasta), pegfilgrastim-apgf (Nyvepria), to decrease the incidence of febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.
The FDA approval was based on the review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of the bioisimilar to its reference product, according to a news release issued by Pfizer, manufacturer of pegfilgrastim-apgf.
“Chemotherapy-induced febrile neutropenia is a relatively common and severe side effect of some cancer treatments that could cause significant complications and can result in the alteration of treatment regimens,” said Ali McBride, PharmD, MS, BCPS, BCOP, Immediate Past President of the Association of Community Cancer Centers. “The FDA approval of [pegfilgrastim-apgf] provides clinicians with an additional long-acting treatment option that can help prevent infections in patients undergoing myelosuppressive chemotherapy.”
Pfizer has also filed for regulatory approval with the European Medicines Agency for the biosimilar product—the application is currently under review.
Pegfilgrastim-apgf is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.