for decrease incidence of infection in patients receiving myelosuppressive chemotherapy
FDA approved Ennumo (pegfilgrastim-pccg) as a biosimilar to Neulasta, adding another lower-cost option for managing chemotherapy-induced neutropenia. Approval follows the standard 351(k) biosimilar pathway.
Chemotherapy-induced neutropenia is a dangerous drop in neutrophils — the white blood cells that normally defend the body against bacterial and fungal infections — and it often forces cancer treatment to be delayed or reduced. Ennumo is a long-acting form of G-CSF, a natural hormone that signals the bone marrow to make and mature more of these infection-fighting cells. Because the drug replenishes the same cell type chemotherapy wipes out, it may lower the chance of serious infection during treatment cycles.