Results from a Phase 3 clinical trial, RECOVER, evaluating Spectrum Pharmaceuticals' (SPPI -2.4%) ROLONTIS (eflapegrastim) for reducing the duration of severe neutropenia (low levels of a type of white blood cell called neutrophils) in breast cancer patients receiving chemo showed its non-inferiority (no worse than) to Amgen's (AMGN -0.8%) NEULASTA (pegfilgrastim). The data were presented at the San Antonio Breast Cancer Symposium.
The non-inferiority of ROLONTIS was maintained across all four treatment cycles. The incidences of severe neutropenia in the eflapegrastim and pegfilgrastim arms were 20% and 24%, respectively, with 14% less relative risk for the former.
RECOVER is the second late-stage study to demonstrate the non-inferiority of eflapegrastim to pegfilgrastim. Results from ADVANCE were announced at ASCO in June.
Eflapegrastim a long-acting granulocyte colony-stimulating factor (G-CSF).
The company plans to file its U.S. marketing application by year-end.
Now read: Danger Zone: Rise Of The Noise Traders »
Subscribe for full text news in your inbox