Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) rose after the company disclosed that ROLONTIS met its primary endpoint in the Phase 3 ADVANCE study.
The company, based out of Henderson, Nevada, announced Monday that ROLONTIS, ADVANCE, 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.
Spectrum CEO Joe Turgeon was quoted in the news release as such: “The positive top line data from our Phase 3 study is an important milestone for Spectrum as we continue to move our Company forward.
"Also, the completion of enrollment of our second Phase 3, the RECOVER study, keeps us on track to file a BLA in the fourth quarter of 2018. ROLONTIS has the potential to be an important alternative for physicians and patients within this multibillion dollar market."
Spectrum is a leading biotechnology Company focused on acquiring, developing, and commercializing drug products, with a primary focus in Hematology and Oncology. Spectrum currently markets six hematology/oncology drugs, and has an advanced stage pipeline that has the potential to transform the Company.
Spectrum screamed higher $1.40, or 6.8%, to $21.97.