US biotech company Spectrum Pharmaceuticals said that it has submitted a Biologics License Application (BLA) for ROLONTIS (eflapegrastim) to the US Food and Drug Administration (FDA), seeking approval for the drug to be used as a treatment for chemotherapy-induced neutropenia.
The BLA for ROLONTIS is backed by findings of two similarly designed phase 3 clinical trials, called ADVANCE and RECOVER.
The late-stage trials assessed the safety and efficacy of the drug in 643 early-stage breast cancer patients for the treatment of neutropenia resulting from myelosuppressive cytoxic chemotherapy.
ADVANCE clinical trial was held under a special protocol assessment (SPA) with the Agency. In both the clinical trials, ROLONTIS showed the pre-specified hypothesis of non-inferiority (NI) in Duration of Severe Neutropenia (DSN) and an identical safety profile to pegfilgrastim.
The Spectrum Pharmaceuticals drug also showed non-inferiority to pegfilgrastim in the DSN for all four cycles in the two late-stage studies.
Joe Turgeon – President and CEO of Spectrum Pharmaceuticals said: “ROLONTIS is an important and significant future growth driver for our company.
“Today’s milestone brings us one step closer to bringing the first novel G-CSF to healthcare providers in over 15 years in a large market that is familiar to Spectrum.”