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# Spectrum BLA for Rolontis Withdrawn After FDA Request
- URL: https://www.fdaweb.com/spectrum-bla-for-rolontis-withdrawn-after-fda-request/
- Published: 2019-03-15T12:00:00.000Z
- Updated: 2026-09-15T01:12:58.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5143626

Spectrum Pharmaceuticals has withdrawn a BLA for Rolontis (eflapegrastim), a treatment for chemotherapy-induced neutropenia in patients undergoing myelosuppressive chemotherapy, after FDA requested additional manufacturing-related information. The company says it plans to submit a revised BLA as soon as possible.

FDA’s review did not cite concerns related to the pre-clinical and clinical modules of the BLA or the need for additional clinical studies, Spectrum says.