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