FDA to Review Eflapegrastim for Chemo-Induced Neutropenia

January 2, 2020 – The FDA has accepted a biologics license application (BLA) to review eflapegrastim for the management of chemotherapy-induced neutropenia, according to Spectrum Pharmaceuticals, the developer of the novel long-acting granulocyte-colony stimulating factor (G-CSF). The BLA is based on findings from the 2 similarly designed ADVANCE2 and RECOVER3 trials, both of which demonstrated the prespecified hypothesis of noninferiority in duration of … (leggi tutto)