Rolontis is non inferior to pegfilgrastim for mamagement of severe chemotherapy- induced neutropenia.- Spectrum Pharma

Spectrum Pharmaceuticals, Inc. announced that the first Phase III study of Rolontis (eflapegrastim), ADVANCE, has met its primary endpoint of non-inferiority in Duration of Severe Neutropenia in comparison to pegfilgrastim. This study evaluated the safety and efficacy of Rolontis in the management of chemotherapy-induced neutropenia in 406 patients with early-stage breast cancer.

The incidence of adverse events in this study was similar between the Rolontis and the pegfilgrastim arms. The Company also announced that RECOVER, the second Phase III study, has completed enrollment.

In accordance with the FDA Special Protocol Assessment, Phase III ADVANCE study was a multicenter, randomized, active-controlled trial that enrolled 406 early-stage breast cancer patients, who receive docetaxel and cyclophosphamide chemotherapy every 21 days. Patients were randomized 1:1 to treatment with Rolontis or pegfilgrastim. The primary study endpoint was the Duration of Severe Neutropenia (Absolute Neutrophil Counts [ANC] <0.5�109 l in cycle 1 of chemotherapy based on central laboratory assessment of anc over the 21 day cycle.>

Comment: Spectrum Pharmaceuticals Inc. plans to file for approval at the FDA of Rolontis later this year.