Spectrum Pharmaceuticals, Inc., a biotechnology company with a primary focus in hematology and oncology, has submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for Rolontis (eflapegrastim).
The BLA is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of Rolontis in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive cytoxic chemotherapy.
The study ADVANCE was conducted under a special protocol assessment with the agency. In both studies, Rolontis demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia and a similar safety profile to pegfilgrastim.
Rolontis also demonstrated non-inferiority to pegfilgrastim in the duration of severe neutropenia across all 4 cycles (all NI p<0.0001) in both studies.
(Source: Spectrum Pharmaceuticals, Inc.)