BioCentury
ARTICLE | Clinical News

Spectrum's Rolontis meets in second Phase III for chemotherapy-induced neutropenia

July 6, 2018 4:43 PM UTC

Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) said Rolontis eflapegrastim met the primary endpoint of non-inferiority to Neulasta pegfilgrastim in the Phase III RECOVER trial in 237 early stage breast cancer patients who received docetaxel and cyclophosphamide every 21 days. The open-label, U.S. trial's primary endpoint measured the duration of severe neutropenia, defined as the number of days with an absolute neutrophil count of <0.5x109/L in cycle one of chemotherapy.

The company reiterated its plan to submit a BLA to FDA next quarter for the long-acting G-CSF analog to treat chemotherapy-induced neutropenia...