Spectrum Pharma withdraws BLA for Rolontis

Shares of Spectrum Pharmaceuticals (Nasdaq-GS: SPPI) dropped 8% in pre-market trading on Friday, after it revealed a further disappointment in the development of its lead product candidate Rolontis (eflapegrastim), a novel therapy for the management of chemotherapy-induced neutropenia in patients undergoing myelosuppressive chemotherapy.

Following a request from the US Food and Drug Administration for additional manufacturing-related information for Rolontis, the company has voluntarily withdrawn its Biologics License Application (BLA).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 stock recovered to some extents, closing down 2.9% at $9.98 on Friday.

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.