FDA accepts BLA resubmission for eflapegrastim to treat febrile neutropenia.
Spectrum Pharmaceuticals announced that the resubmitted Biologics License Application (BLA) for eflapegrastim has been accepted for filing.
The 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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