Drug news
FDA accepts BLA for Rolontis for the treatment of neutropenia due to myelosuppressive chemotherapy and sets a PDUFA date of October 24, 2020.- Spectrum Pharma
Spectrum Pharmaceuticals announced that the Biologics License Application (BLA) for Rolontis (eflapegrastim) was accepted for review by the FDA and set a Prescription Drug User Fee Act (PDUFA) date of 24 October 2020.
The BLA for Rolontis is supported by data from two identically designed Phase III 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 chemotherapy.
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