WALTHAM, MA, USA I September 8, 2014 I 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.
About Rolapitant
Rolapitant is a potent and selective NK-1 receptor antagonist with an extended plasma half-life that is being developed for the prevention of CINV. NK-1 receptors are highly concentrated in the brain and bind the neurokinin substance P. Activation of NK-1 receptors plays a central role in nausea and vomiting induced by emetogenic stimuli, including certain cancer chemotherapies. NK-1 receptor antagonists have been demonstrated to improve the management of nausea and vomiting experienced by cancer patients undergoing emetogenic chemotherapy. The safety and tolerability of single and repeat doses of rolapitant have been assessed in more than 2,500 healthy volunteers and patients. Rolapitant is being developed both in oral and intravenous formulations. TESARO licensed exclusive rights for the development, manufacture, commercialization and distribution of rolapitant from OPKO Health, Inc.
About Chemotherapy-Induced Nausea and Vomiting (CINV)
CINV is estimated to afflict over 70% of cancer patients undergoing emetogenic chemotherapy and, if not prevented, may possibly result in a delay or even discontinuation of chemotherapy treatment. Prolonged nausea and vomiting may result in unwanted weight loss, dehydration and malnutrition, as well as hospitalization.
About TESARO
TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.
SOURCE: Tesaro
Post Views: 24
WALTHAM, MA, USA I September 8, 2014 I 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.
About Rolapitant
Rolapitant is a potent and selective NK-1 receptor antagonist with an extended plasma half-life that is being developed for the prevention of CINV. NK-1 receptors are highly concentrated in the brain and bind the neurokinin substance P. Activation of NK-1 receptors plays a central role in nausea and vomiting induced by emetogenic stimuli, including certain cancer chemotherapies. NK-1 receptor antagonists have been demonstrated to improve the management of nausea and vomiting experienced by cancer patients undergoing emetogenic chemotherapy. The safety and tolerability of single and repeat doses of rolapitant have been assessed in more than 2,500 healthy volunteers and patients. Rolapitant is being developed both in oral and intravenous formulations. TESARO licensed exclusive rights for the development, manufacture, commercialization and distribution of rolapitant from OPKO Health, Inc.
About Chemotherapy-Induced Nausea and Vomiting (CINV)
CINV is estimated to afflict over 70% of cancer patients undergoing emetogenic chemotherapy and, if not prevented, may possibly result in a delay or even discontinuation of chemotherapy treatment. Prolonged nausea and vomiting may result in unwanted weight loss, dehydration and malnutrition, as well as hospitalization.
About TESARO
TESARO is an oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. For more information, visit www.tesarobio.com.
SOURCE: Tesaro
Post Views: 24
