Rolontis filed with FDA for chemotherapy-induced neutropenia.- Spectrum Pharma.

Spectrum Pharmaceuticals announced that the company submitted a Biologics License Application (BLA) with the FDA for Rolontis (eflapegrastim) for chemotherapy-induced neutropenia. The BLA for Rolontis is supported by data from two identically designed Phase III 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 cytoxic chemotherapy.

The study ADVANCE was conducted under a special protocol assessment (SPA) with the Agency. 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 studies.>

Comment: Rolontis is being positioned to take on the market of Amgen's blockbuster Neulasta (pegfligrastim) for the prevention of neutropenia in patients undergoing chemotherapy. Neulasta has been the only long-acting GSF on the market, but biosimilars are on the way. The FDA approved Mylan NV/Biocon Ltd.'s pegfilgrastim biosimilar Fulphila (pegfilgrastim-jmdb) in June 2018.