Spectrum Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for Eflapegrastim

On April 11, 2022 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that the resubmitted Biologics License Application (BLA) for eflapegrastim has been accepted for filing (Press release, Spectrum Pharmaceuticals, APR 11, 2022, View Source [SID1234611930]). The U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) goal date of September 9, 2022. Spectrum is seeking an indication to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

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"The acceptance of the BLA resubmission is an important incremental step forward in the regulatory review process," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. "We are actively working with the agency as they conduct their review and look forward to the potential approval of this novel product."

About Eflapegrastim

Eflapegrastim is a novel, long-acting granulocyte colony-stimulating factor (G-CSF), Spectrum is seeking an indication to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. The BLA for eflapegrastim is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of eflapegrastim in 643 early-stage breast cancer patients for the management of neutropenia due to myelosuppressive chemotherapy. In both studies, eflapegrastim demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. Eflapegrastim also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both trials.