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# FDA Approves Spectrum Pharma’s Rolvedon
- URL: https://www.fdaweb.com/fda-approves-spectrum-pharmas-rolvedon/
- Published: 2022-09-09T12:00:00.000Z
- Updated: 2026-09-14T17:58:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152708

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.”