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FDA to Review Eflapegrastim for Chemo-Induced Neutropenia

Gina Columbus @ginacolumbusonc
Published: Thursday, Jan 02, 2020

The FDA has accepted a biologics license application (BLA) to review eflapegrastim (Rolontis) for the management of chemotherapy-induced neutropenia, according to Spectrum Pharmaceuticals, the developer of the novel long-acting granulocyte-colony stimulating factor (G-CSF).1

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 severe neutropenia (DSN) and a similar safety profile to pegfilgrastim (Neulasta) in patients with early-stage breast cancer who are receiving myelosuppressive chemotherapy. Additionally, in each of the 2 studies, eflapegrastim showed noninferiority to pegfilgrastim in the DSN across all 4 cycles (P <.0001).

Under the Prescription Drug User Fee Act, the FDA is scheduled make a decision on the application by October 24, 2020.

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