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Spectrum says Phase 3 Rolontis study met primary endpoint.

Spectrum Pharmaceuticals announced that the first Phase 3 study of ROLONTIS, 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 3 study, has completed enrollment. In accordance with the FDA Special Protocol Assessment, Phase 3 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 in Cycle 1 of chemotherapy, based on central laboratory assessment of ANC over the 21 day cycle. In January 2012, Spectrum entered into a licensing agreement with Hanmi Pharmaceuticals, gaining global rights for ROLONTIS.

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Publication:The Fly
Article Type:Clinical report
Date:Feb 5, 2018
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