Spectrum Pharmaceuticals provides BLA filing update for Rolontis (eflapegrastim)

Spectrum

15 March 2019 - Spectrum Pharmaceuticals announced today that due to the U.S. FDA's request for additional manufacturing-related information for Rolontis, the company has voluntarily withdrawn its Biologics License Application. 

Spectrum plans to resubmit a revised application 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 29 March 2019, the day that the FDA’s initial 60-day review period ends.

Read Spectrum Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , US , Dossier