Tesaro, Inc. has announced that it has submitted a new drug application for its drug, rolapitant, to the U.S. Food and Drug Administration for the prevention of chemotherapy-induced nausea and vomiting (CINV). Rolapitant is a neurokinin-1 (NK-1) receptor antagonist that is being developed as both oral and intravenous formulations. Rolapitant has been studied in about 1,400 patients receiving chemotherapy, a treatment which commonly causes nausea and vomiting.
Rolapitant was studied in combination with granisetron, a 5-HT3 receptor antagonist, and dexamethasone in patients treated with carboplatin, cyclophosphamide, cytarabine, daunorubicin, doxorubicin, epirubicin, or irinotecan. Researchers found that those treated with the rolapitant, granisetron, and dexamethasone had a significantly higher complete response rate compared with those that received only granisetron and dexamethasone for delayed phase CINV (P<0.001).
Researchers estimate that over 70% of patients with cancer undergoing chemotherapy experience CINV. If not prevented, CINV may decrease quality of life during cancer treatment, as well as delay or force the discontinuation of treatment with chemotherapy. Untreated nausea and vomiting can result in dehydration and malnutrition, thereby resulting in hospitalization.
OPKO Health, Inc. OPK, reported that its licensee, TESARO, Inc. 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.