By Colin Kellaher

Spectrum Pharmaceuticals Inc. on Friday said the U.S. Food and Drug Administration has turned away the company's application for Rolontis because of deficiencies related to manufacturing.

The Henderson, Nev., biopharmaceutical company said it received a complete response letter from the FDA, indicating that the agency won't approve the application in its current form, and that a manufacturing reinspection will be needed.

Spectrum, which was seeking FDA approval of Rolontis for the treatment of neutropenia in patients receiving myelosuppressive anticancer drugs, said it is seeking further clarification from the FDA and plans to meet with the agency as soon as possible.

The FDA had previously set a target action date of Oct. 24, 2020, for Spectrum's application for Rolontis, but the agency last year deferred action because it had been unable to inspect the product's manufacturing plant in South Korea as a result of travel restrictions related to the coronavirus pandemic.

Spectrum earlier this year said the FDA had begun its preapproval inspection of the plant, which the company believed would mark the final step in the Rolontis review process.

"We are disappointed with this outcome and look forward to fully understanding the remediation timelines for the program," Spectrum said Friday.

Shares of Spectrum, which closed Thursday at $3.25, fell more than 30% in premarket trading Friday.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

08-06-21 0809ET