TESARO Announces Submission Of Rolapitant New Drug Application To FDA

TESARO, Inc. TSRO, an oncology-focused biopharmaceutical company, today announced that it has submitted the New Drug Application (NDA) for oral rolapitant to the U.S. Food and Drug Administration (FDA). Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist developed for the prevention of chemotherapy-induced nausea and vomiting (CINV). "TESARO is committed to advancing new therapeutic options for patients with cancer, and the oral rolapitant NDA submission represents a significant milestone for the Company," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "We believe rolapitant could become an important new treatment for the prevention of nausea and vomiting for patients undergoing emetogenic chemotherapy." The oral rolapitant NDA is supported by data from four controlled studies covering a spectrum of patients receiving emetogenic chemotherapy. One study enrolled patients receiving Moderately Emetogenic Chemotherapy (MEC), and three studies enrolled patients receiving cisplatin-based Highly Emetogenic Chemotherapy (HEC). The top-line results of each of the three Phase 3 studies of rolapitant were previously announced by TESARO and were presented in detail at the American Society for Clinical Oncology (ASCO) annual meeting in June 2014.