The Biologics License Application (BLA) for Rolontis (eflapegrastim; Spectrum) has been submitted to the Food and Drug Administration (FDA) for the treatment of chemotherapy-induced neutropenia.
Rolontis is a long-acting granulocyte colony-stimulating factor (G-CSF) developed using Spectrum’s proprietary technology. The BLA was supported by data from two Phase 3 trials (ADVANCE and RECOVER) which evaluated the safety and efficacy of Rolontis in early-stage breast cancer patients (N=643) who had neutropenia due to myelosuppressive cytotoxic chemotherapy. In both studies, treatment with Rolontis was found to be non-inferior to pegfilgrastim for the primary endpoint of absolute risk reduction of severe neutropenia.
“Today’s milestone brings us one step closer to bringing the first novel G-CSF to healthcare providers in over 15 years,” said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals.
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