Rolapitant final successful Phase III trial for CINV (Nausea)- Tesaro

Tesaro Inc. has announced positive top-line results from the third and final Phase III trial of rolapitant, an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of Chemotherapy-induced Nausea and Vomiting (CINV). The rolapitant arm in this trial, which enrolled patients receiving cisplatin-based, highly emetogenic chemotherapy (HEC), successfully achieved statistical significance over the standard therapy arm for the primary and all secondary endpoints. The adverse event profile for rolapitant remains consistent with that seen in previous clinical studies.

Preparations continue in support of a submission of a New Drug Application (NDA) to the FDA in mid-2014.