MIAMI--(BUSINESS WIRE)--OPKO Health, Inc. (NYSE:OPK), reported that its licensee, TESARO, Inc. (Nasdaq:TSRO), has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of oral rolapitant, an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV).
This NDA is supported by data from four controlled studies covering a spectrum of patients receiving chemotherapy that commonly causes nausea and vomiting. The top-line results of three of the Phase 3 studies were previously announced by TESARO and were presented in detail at the American Society for Clinical Oncology (ASCO) annual meeting in June 2014.
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