TESARO Announces Acceptance for Review of Niraparib Marketing Authorization Application by EMA
October 27 2016 - 4:05PM
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 NiraparibNiraparib 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
CancerApproximately 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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