Spectrum Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for Eflapegrastim

Date:
Apr 14, 2022

Spectrum Pharmaceuticals Announces FDA Acceptance of BLA Resubmission for Eflapegrastim

FDA has assigned September 9, 2022 as the PDUFA date

Spectrum Pharmaceuticals announced that the resubmitted Biologics License Application (BLA) for eflapegrastim has been accepted for filing. 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.

“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.”