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2016-10-27

TESARO, Inc.: TESARO Announces Acceptance for Review of Niraparib Marketing Authorization Application by EMA

WALTHAM, Mass., Oct. 27, 2016 (GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO),
an oncology-focused biopharmaceutical company, today announced that the
Marketing Authorisation Application (MAA) for niraparib has been submitted to
and accepted for review by the European Medicines Agency (EMA) for the
maintenance treatment of patients with platinum-sensitive, recurrent ovarian
cancer who are in response to platinum-based chemotherapy. With this
acceptance, the review of the niraparib marketing authorisation application
in the Centralised Procedure will now begin.

"TESARO is committed to improving the lives of patients with cancer by
responsible development and commercialization, and the validation of the
niraparib MAA represents a significant milestone for the Company," said Mary
Lynne Hedley, Ph.D., President and COO of TESARO. "We believe niraparib could
become an important new treatment option for patients. We look forward to
working with the EMA during the review process and expect to complete our
rolling NDA submission to the FDA for niraparib imminently."

The niraparib MAA is supported by data from the ENGOT-OV16/NOVA trial, which
is a double-blind, placebo-controlled, international Phase 3 study of
niraparib that enrolled 553 patients with recurrent ovarian cancer who were
in a response to their most recent platinum-based chemotherapy. The full
results of the NOVA trial were presented in detail at the European Society
for Medical Oncology (ESMO) 2016 Congress in Copenhagen on October 8, 2016
and were published at the same time in The New England Journal of Medicine
.

"The validation of our MAA for niraparib today marks an important step towards
globalizing our mission of providing transformative therapies to people
bravely facing cancer," said Orlando Oliveira, Senior Vice President and
General Manager of TESARO International. "With the MAA for oral rolapitant
already under review by the EMA, we are well positioned for two potential
product launches in Europe in 2017."

About Niraparib
Niraparib is an oral, once-daily PARP inhibitor that is currently being
evaluated in four ongoing pivotal trials. TESARO is building a robust
niraparib franchise by assessing activity across multiple tumor types and by
evaluating several potential combinations of niraparib with other
therapeutics. The ongoing development program for niraparib includes a Phase
3 trial in patients with platinum-sensitive, recurrent ovarian cancer (the
NOVA trial); a Phase 3 trial in patients with first-line ovarian cancer (the
PRIMA trial); a registrational Phase 2 treatment trial in patients with
ovarian cancer (the QUADRA trial); and a Phase 3 trial for the treatment of
patients with BRCA-positive breast cancer (the BRAVO trial). Several
combination studies are also underway, including trials of niraparib plus
pembrolizumab and niraparib plus bevacizumab. Janssen Biotech has licensed
rights to develop and commercialize niraparib specifically for patients with
prostate cancer worldwide, except in Japan.

Niraparib is an investigational agent and, as such, has not been approved by
the U.S. Food and Drug Administration, EMA, or any other regulatory agencies.

About Ovarian Cancer
Approximately 22,000 women are diagnosed each year with ovarian cancer in the
United States, and more than 65,000 women are diagnosed annually in Europe.
Ovarian cancer is the fifth most frequent cause of cancer death among women.
Despite high response rates to platinum-based chemotherapy in the second-line
advanced treatment setting, approximately 85% of patients will experience
recurrence within two years. If approved, niraparib may address the difficult
"watchful waiting" periods experienced by patients with recurrent ovarian
cancer in between cycles of platinum-based chemotherapy.

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. Examples of forward-looking
statements contained in this press release include, among others, statements
regarding our expectation to launch two products in Europe in 2017.
Forward-looking statements in this release involve substantial risks and
uncertainties that could cause our research and pre-clinical development
programs, 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, risks related to our intellectual property, the uncertainties
inherent in the execution and completion of clinical trials, uncertainties
surrounding the timing of availability of data from our clinical trials,
risks regarding ongoing discussions with and actions by regulatory
authorities, patient accrual rates for clinical trials, risks from
competitors, and other matters that could affect the timing of availability
of data from or initiation of our clinical trials, uncertainties regarding
regulatory approvals, uncertainties regarding certain expenditures, risks
related to manufacturing and supply, 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, 2015 and its Quarterly Report on Form 10-Q for the quarter ended June 30,
2016.

Investor/Media Contact:

Jennifer Davis
Sr. Director, Corporate Development & Investor Relations
+1.781.325.1116 or jdavis@tesarobio.com

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This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: TESARO, Inc. via Globenewswire

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