Eflapegrastim Application Resubmitted to FDA for Chemo-Induced Neutropenia

October 25, 2019 – An updated biologics license application (BLA) has been submitted to the FDA for 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 application is based on data from the two similarly designed ADVANCE2 and RECOVER3 trials, both of which demonstrated the prespecified hypothesis of … (leggi tutto)