TESARO Announces Validation of Marketing Authorisation Application for Oral Rolapitant by the European Medicines Agency

WALTHAM, Mass., March 23, 2016 -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the Marketing Authorisation Application (MAA) for oral rolapitant has been submitted to and validated by the European Medicines Agency. Rolapitant is a substance P/neurokinin-1 (NK-1) receptor antagonist that is marketed by TESARO in the United States under the brand name VARUBI®.

“TESARO is committed to advancing new therapeutic options for patients with cancer, and the oral rolapitant MAA 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 option for the prevention of nausea and vomiting for patients in Europe who are undergoing emetogenic chemotherapy.”

The oral rolapitant MAA 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 presented in detail at the American Society for Clinical Oncology (ASCO) annual meeting in June 2014. Oral rolapitant was approved by the U.S. Food and Drug Administration on September 1, 2015 and is marketed by TESARO in the United States under the brand name VARUBI®.  

“TESARO has an exciting pipeline of oncology therapeutics, and with the filing of our MAA for oral rolapitant today and our planned niraparib MAA filing in the second half of this year, we look forward to globalizing our mission of providing transformative therapies to people bravely facing cancer,” said Orlando Oliveira, Senior Vice President and General Manager of TESARO International.

About Chemotherapy-Induced Nausea and Vomiting (CINV)

Chemotherapy-induced nausea and vomiting is a debilitating, yet often preventable, side effect of chemotherapy.

More than 50% of patients undergoing highly or moderately emetogenic chemotherapy may experience delayed CINV (25 to 120 hours post chemotherapy)—even when prescribed a 5-HT₃ receptor antagonist and corticosteroid.

Blocking both 5-HT₃ and NK-1 receptors has been shown to offer better control of nausea and vomiting than inhibiting 5-HT₃ receptors alone. Adding a single dose of VARUBI to an antiemetic regimen, including a 5-HT₃ receptor antagonist and corticosteroid, further improves prevention of CINV in the delayed phase following chemotherapy.

About VARUBI® (Rolapitant)

VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. VARUBI is contraindicated in patients receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid use of pimozide; monitor for adverse events if concomitant use with other CYP2D6 substrates with a narrow therapeutic index cannot be avoided. Please see full prescribing information, including additional important safety information, available at www.varubirx.com.

An intravenous formulation of rolapitant is also being developed. TESARO licensed exclusive rights for the development, manufacture, commercialization, and distribution of VARUBI (rolapitant) from OPKO Health, Inc.

About TESARO

TESARO is an oncology-focused biopharmaceutical company devoted to providing transformative therapies to people bravely facing cancer. For more information, visit www.tesarobio.com.

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 expectations with respect to regulatory submissions and approvals, 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. 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, 2015, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2015.

Investor/Media Contact:

Jennifer Davis
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+1.781.325.1116 or [email protected]