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# Covid Travel Ban Blocks Spectrum Cancer Drug Inspection
- URL: https://www.fdaweb.com/covid-travel-ban-blocks-spectrum-cancer-drug-inspection/
- Published: 2020-10-26T12:00:00.000Z
- Updated: 2026-09-14T16:34:01.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147949

FDA has deferred a review action on a Spectrum Pharmaceuticals BLA for Rolontis (eflapegrastim), indicated for treating neutropenia in patients receiving myelosuppressive anti-cancer drugs, because of a Covid-19-related travel restriction that prevents the agency from inspecting the firm’s South Korea manufacturing plant. The agency told the company that the inspection is required before it can approve the submission. Spectrum says it will continue to work actively with FDA to “define an approach for scheduling the required inspection.”

Spectrum describes Rolontis as a novel, long-acting granulocyte colony-stimulating factor. The submission is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the therapy’s safety and efficacy in 643 early-stage breast cancer patients being treated for neutropenia due to myelosuppressive chemotherapy. “In both studies, Rolontis demonstrated the pre-specified hypothesis of non-inferiority in duration of severe neutropenia and a similar safety profile to pegfilgrastim,” it says.