On June 22, 2020 Spectrum Pharmaceuticals, Inc. (NASDAQ-GS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported preclinical data evaluating the administration of ROLONTIS (eflapegrastim) on the same day as chemotherapy (Press release, Spectrum Pharmaceuticals, JUN 22, 2020, View Source [SID1234561283]). The duration of neutropenia in a rat model of chemotherapy induced neutropenia (CIN) was observed to be significantly shorter with eflapegrastim versus pegfilgrastim, regardless of the timing of administration: concomitantly or on the same day post-chemotherapy at 2, 5 or 24 hours post-chemotherapy.
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The poster titled "Chemotherapy induced neutropenia in rats following administration of eflapegrastim or pegfilgrastim on the same day at three different time points and at 24 hours post-chemotherapy" was part of today’s Special Populations, Survivorship, Outcomes, and Supportive Care session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II. ROLONTIS is an investigational drug not approved by the U.S. Food and Drug Administration (FDA) and the BLA (Biologics License Application) is currently under active review by the agency for the treatment of chemotherapy induced neutropenia with a PDUFA date of October 24, 2020.
"These data in rats suggest that eflapegrastim administered at the time of chemotherapy, rather than waiting 24 hours, may be able to provide prophylaxis against chemotherapy induced neutropenia," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "Based on these preclinical results, we recently initiated a Phase 1 clinical trial to compare the effect of same day dosing of eflapegrastim on the duration of neutropenia in patients with early-stage breast cancer when administered on the same day, at varying intervals following docetaxel and cyclophosphamide chemotherapy."