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December 23, 2013
07:14 EDTTSROTESARO achieves primary endpoint in two Phase 3 trials
TESARO announced top-line results for two Phase 3 trials of rolapitant, an investigational neurokinin-1 receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting. The primary endpoint was successfully achieved in each trial and preparations are ongoing in support of a New Drug Application submission for oral rolapitant to the U.S. FDA. The company said, "Despite the availability of preventative therapies and established treatment guidelines for CINV, a significant number of cancer patients still suffer from the debilitating side effects of delayed nausea and vomiting. We are enthusiastic about the potential for this product candidate, with a profile that may include an extended half life, convenient, single-dose oral and intravenous formulations and a lack of CYP3A4-mediated drug interactions." TESARO continues to enroll patients receiving HEC in a third and final Phase 3 trial of rolapitant, and preparations in support of a mid-2014 NDA submission for oral rolapitant are ongoing. Full analyses of data from all three rolapitant pivotal Phase 3 trials will be submitted for presentation at a future medical meeting.
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April 7, 2014
07:27 EDTTSROAmerican Association of Cancer Research to hold annual meeting
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