for decrease incidence of infection in patients receiving myelosuppressive chemotherapy
BLA
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.
About
Chemotherapy-induced neutropenia is a depletion of infection-fighting white blood cells, which is a common and serious side effect of many cancer treatments. Ennumo is a long-acting version of a human protein (G-CSF) that spurs the bone marrow to produce more of these protective cells. By boosting neutrophil counts, the drug can help lower the risk of dangerous infections during each chemotherapy cycle.