TESARO Reports NDA Submission Of Rolapitant To U.S. FDA - Quick Facts

(RTTNews) - TESARO Inc. (TSRO), an oncology-focused biopharmaceutical company, has submitted the New Drug Application or NDA for oral rolapitant to the U.S. Food and Drug Administration or FDA. Rolapitant is an investigational neurokinin-1 or NK-1 receptor antagonist developed for the prevention of chemotherapy-induced nausea and vomiting or 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, and three trials enrolled patients receiving cisplatin-based Highly Emetogenic Chemotherapy.