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Treatment for Nausea/Vomiting -- Chemotherapy Induced

Update: Varubi (rolapitant) Now FDA Approved - September 1, 2015

Tesaro Announces Submission of Rolapitant NDA to U.S. Food and Drug Administration

WALTHAM, Mass., Sept. 8, 2014 (GLOBE NEWSWIRE) -- Tesaro, Inc. (Nasdaq: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

To the extent that statements contained in this press release are not descriptions of historical facts regarding Tesaro, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the initiation and conduct of clinical trials, expectations with respect to regulatory submissions and approvals, challenges associated with expanding operations to include commercial activities, and other matters that could affect the availability or commercial potential of our drug candidates. Tesaro undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see Tesaro's Annual Report on Form 10-K for the year ended December 31, 2013 and other filings Tesaro makes with the Securities and Exchange Commission.

Posted: September 2014

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