On September 9, the U.S. Food and Drug Administration (FDA) approved eflapegrastim-xnst injection (Rolvedon)—a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation—to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. This is the first novel long-acting G-CSF product approved in over 20 years.
Eflapegrastim is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. The biologics application for eflapegrastim was supported by data from two identically designed phase III, randomized, open-label, noninferiority clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of eflapegrastim in 643 patients with early-stage breast cancer for the management of neutropenia due to myelosuppressive chemotherapy.
In both studies, eflapegrastim demonstrated the prespecified hypothesis of noninferiority in mean duration of severe neutropenia and a similar safety profile to pegfilgrastim. Eflapegrastim also demonstrated noninferiority to pegfilgrastim in the mean duration of severe neutropenia across all four cycles (all noninferiority P < .0001) in both trials.
Important safety information is available at sppirx.com.
