Spectrum Pharmaceuticals Provides BLA Filing Update for ROLONTIS® (eflapegrastim)

HENDERSON, Nev.–(BUSINESS WIRE)–Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI) announced today that
due to the U.S. Food and Drug Administration’s (FDA) request for
additional manufacturing-related information for ROLONTIS, the company
has voluntarily withdrawn its Biologics License Application (BLA).
Spectrum plans to resubmit a revised BLA as soon as possible.

The FDA did not cite concerns related to the pre-clinical and clinical
modules of the BLA or the need for additional clinical studies.
Spectrum’s decision to withdraw the BLA was the result of the company
needing more time to provide certain additional manufacturing-related
information, which was required before March 29, 2019, the day that the
FDA’s initial 60-day review period ends.

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