The Food and Drug Administration (FDA) has accepted for filing the resubmitted Biologics License Application (BLA) for eflapegrastim to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia.
Eflapegrastim is a novel, long-acting granulocyte colony-stimulating factor. The BLA is supported by data from two phase 3 trials, ADVANCE (ClinicalTrials.gov Identifier: NCT02643420) and RECOVER (ClinicalTrials.gov Identifier: NCT02953340), which evaluated the safety and efficacy of eflapegrastim in 643 early-stage breast cancer patients who had neutropenia due to myelosuppressive cytotoxic chemotherapy.
Findings from both trials showed that the primary endpoint of noninferiority in the duration of severe neutropenia between eflapegrastim and pegfilgrastim was met. No statistically significant differences in adverse events were observed between the treatment arms.
“The acceptance of the BLA resubmission is an important incremental step forward in the regulatory review process,” said Tom Riga, President and CEO of Spectrum Pharmaceuticals. “We are actively working with the agency as they conduct their review and look forward to the potential approval of this novel product.”
A Prescription Drug User Fee Act (PDUFA) target date of September 9, 2022 has been set for the application.
- Spectrum Pharmaceuticals announces FDA acceptance of BLA resubmission for eflapegrastim. News release. Spectrum Pharmaceuticals. Accessed April 11, 2022. https://www.businesswire.com/news/home/20220411005203/en/Spectrum-Pharmaceuticals-Announces-FDA-Acceptance-of-BLA-Resubmission-for-Eflapegrastim
- Spectrum Pharmaceuticals receives Complete Response Letter from FDA for Rolontis® (eflapegrastim). News release. Spectrum Pharmaceuticals. August 6, 2021. Accessed April 11, 2022. https://investor.sppirx.com/news-releases/news-release-details/spectrum-pharmaceuticals-receives-complete-response-letter-fda-1