Spectrum Pharma withdraws license application for Rolontis after FDA seeks informatio

Spectrum Pharma withdraws license application for Rolontis after FDA seeks information on manufacturing

Spectrum Pharmaceuticals Inc. shares slid 7.6% in premarket trade Friday, after the company said it is withdrawing its Biologics License Application for Rolontis after the U.S. Food and Drug Administration asked for manufacturing-related information. The company said the decision was made because it needs more time to comply with the FDA request and that it will resubmit a BLA as soon as possible. "We are continuing to have productive discussions with the FDA and will deliver the additional information needed to support the application, " CEO Joe Turgeon said in a statement. Rolontis is a treatment for the management of chemotherapy-induced neutropenia in patients undergoing myelosuppressive chemotherapy. Neutropenia is a common side effect of myelosuppressive chemotherapy that increases the risk of infection and reduces patients' ability to fight infection. Spectrum shares have fallen 44% in the last 12 months, while the S&P 500 has gained 2.2%.

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