The U.S. FDA rejected Spectrum Pharmaceuticals’ application for neutropenia treatment Rolontis (ingredient: eflapegrastim), notifying that the regulator would reinspect the manufacturing site. Spectrum is a U.S. partner firm for Hanmi Pharmaceutical.

The latest decision is likely to delay approval for Rolontis in the U.S.

On Friday, Spectrum said it has received a complete response letter (CRL) from the FDA, which means that the regulator would not authorize the application.

According to Spectrum, the FDA mentioned the CRL deficiencies related to Rolontis manufacturing and demanded a reinspection.

Spectrum said it would ask for further clarification from the FDA and meet with the regulator as soon as possible.

“We are disappointed with this outcome and look forward to fully understanding the remediation timelines for the program,” said Joe Turgeon, CEO of Spectrum Pharmaceuticals. “We continue to believe in Rolontis and plan to complete the regulatory process to bring Rolontis to market diligently.”

Hanmi Pharmaceutical said it would seek response measures with Spectrum.

“Unfortunately, the company received the CRL, but we are analyzing what to improve in detail,” an official at Hanmi said.

Spectrum received the CRL from the FDA not only because of the inspection on Hanmi’s manufacturing site in May, the official explained. In addition, the FDA might have found problems with Spectrum’s drug product (DP) and a U.S. clinical manufacturing organization (CMO) that manufactured Spectrum’s product, he added.

“What Hanmi should improve can be resolved quickly,” he said.