COVID-19 travel restrictions hit Spectrum's Rolontis BLA

26 October 2020

Oncology specialist Spectrum Pharmaceuticals (NasdaqGS: SPPI) has announced that the US Food and Drug Administration (FDA) is deferring its action on the company’s Biologics License Application (BLA) for Rolontis (eflapegrastim).

The FDA was unable to conduct an inspection of the Hanmi Bioplant in South Korea during the current review cycle due to restrictions on travel related to the COVID-19 pandemic. This inspection has to be carried out before an approval can be granted. Therefore, the FDA is deferring action on the application until an inspection can be completed.

Spectrum will continue to work actively with the agency to define an approach for scheduling the required inspection. The company has confirmed with the FDA that this is not a Complete Response Letter.

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