FDA Approves Spectrum Pharma’s Rolvedon

FDA has approved a Spectrum Pharmaceuticals BLA for Rolvedon (eflapegrastim-xnst) injection for decreasing the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

The approval of the long-acting granulocyte colony-stimulating factor was supported by data from two identically designed Phase 3 noninferiority clinical trials, ADVANCE and RECOVER, which evaluated the therapy in 643 early-stage breast cancer patients. “In both studies, Rolvedon demonstrated the pre-specified hypothesis of non-inferiority (NI) in mean duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim” [Amgen’s Neulasta], Spectrum says. “Rolvedon also demonstrated non-inferiority to pegfilgrastim in the mean DSN across all four cycles (all NI p<0.0001) in both trials.”