On June 1, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that the U.S. Food and Drug Administration (FDA) is "on site" for the ROLONTIS (eflapegrastim) manufacturing facility inspection (Press release, Spectrum Pharmaceuticals, JUN 1, 2021, View Source [SID1234583302]). Spectrum previously received notification from the agency that it would defer its decision on the BLA for ROLONTIS because an inspection of the Hanmi Bioplant in South Korea could not be conducted due to restrictions on travel related to the COVID-19 pandemic.
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"I would like to confirm that the FDA has initiated its inspection of the ROLONTIS manufacturing facility," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals.
About ROLONTIS
ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The BLA for ROLONTIS is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both trials.