Breast Cancer

Spectrum’s eflapegrastim meets primary endpoint of non-inferiority in phase III breast cancer study

The first phase III study (ADVANCE) of eflapegrastim (Rolontis, Spectrum Pharmaceuticals) meets its primary endpoint of non-inferiority in duration of severe neutropenia in comparison with pegfilgrastim. The ADVANCE study is a multicenter, randomized, active-controlled trial that enrolled 406 early-stage breast cancer patients, who received docetaxel and cyclophosphamide chemotherapy every 21 days. The trial also evaluated the safety and efficacy of eflapegrastim vs pegfilgrastim in the management of chemotherapy-induced neutropenia. The incidence of adverse events in this study was similar in both arms.

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