Benzinga | Oct 26, 2020 07:03AM EDT

Spectrum Pharmaceuticals Announces FDA Is Deferring Its Action On Co.'s BLA For ROLONTIS, Citing 'inability to conduct inspection of the drug substance manufacturing facility due to COVID-19 related travel restrictions'

Agency cites inability to conduct inspection of the drug substance manufacturing facility due to COVID-19 related travel restrictions

Spectrum Pharmaceuticals (NASDAQ:SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that an inspection of the Hanmi Bioplant in South Korea is required before the FDA can approve the company's Biologics License Application (BLA) for ROLONTIS. The FDA was unable to conduct an inspection during the current review cycle due to restrictions on travel related to the COVID-19 pandemic. Therefore, the FDA is deferring action on the application until an inspection can be completed. The company will continue to work actively with the FDA to define an approach for scheduling the required inspection. Spectrum has confirmed with the FDA that this is not a Complete Response Letter.

"We are actively working with the FDA to find a way to expedite the plant inspection," said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. "The manufacturing facility is ready for inspection and we are eager to assist the FDA in completing their assessment as soon as possible."