YASTEST
ZUG, Switzerland, Sept. 15, 2017
(GLOBE NEWSWIRE) -- TESARO, Inc. (NASDAQ:TSRO), an oncology-focused
biopharmaceutical company, today announced that the European
Medicines Agency's (EMA) Committee for Medicinal Products for Human
Use (CHMP) has issued a positive opinion for the Company's
marketing authorization application (MAA) for ZEJULA®(niraparib) as
a monotherapy for the maintenance treatment of adult patients with
platinum-sensitive relapsed high grade serous epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in a complete
response (CR) or partial response (PR) to platinum-based
chemotherapy. This opinion will now be referred to the European
Commission (EC), which grants marketing authorization for medicines
in the European Union. Pending the decision by the EC, ZEJULA would
be the first oral, once-daily poly (ADP-ribose) polymerase (PARP)
1/2 inhibitor approved in Europe for use in patients regardless
of BRCA mutation or biomarker
status.
ZEJULA was approved by the Food
and Drug Administration (FDA) on March 27, 2017 and is marketed by
TESARO in the United States, where it is the most frequently
prescribed PARP inhibitor.
"ZEJULA was studied with the
highest level of clinical rigor, and the Phase 3 NOVA trial
generated unsurpassed efficacy results in patients with recurrent
ovarian cancer, including women without germline BRCA mutations who have the most challenging
prognosis and few treatment options," said Mary Lynne Hedley,
Ph.D., President and COO of TESARO. "Today's positive CHMP opinion
brings us one step closer to providing this important new medicine
to a broad population of patients with recurrent ovarian cancer in
Europe."
The ZEJULA marketing authorization
application is supported by data from the ENGOT-OV16/NOVA trial, a
double-blind, placebo-controlled, international Phase 3 study of
ZEJULA that enrolled 553 patients with recurrent ovarian cancer who
had achieved either a PR or CR to their most recent platinum-based
chemotherapy. Approximately two-thirds of study participants did
not have germline BRCA mutations.
Progression in the NOVA study was determined by robust, unbiased,
blinded central review to be the earlier of radiographic or
clinical progression. ZEJULA significantly increased progression
free survival (PFS) in patients with and without
germline BRCA mutations as
compared to the control arm. Treatment with ZEJULA reduced the risk
of disease progression or death by 73% in patients with
germline BRCA mutations (HR 0.27)
and by 55% in patients without germline BRCA mutations (HR 0.45). The magnitude of
benefit was similar for patients entering the trial with a PR or a
CR.
The most common grade 3/4 adverse
reactions to ZEJULA in the NOVA trial included thrombocytopenia
(34%), anemia (25%), neutropenia (20%), and hypertension (9%).
Following dose adjustment based on individual tolerability, the
incidence of grade 3/4 thrombocytopenia was low; approximately 1%
after month two. The majority of hematologic adverse events were
successfully managed via dose modification, and discontinuation of
therapy due to thrombocytopenia, neutropenia and anemia occurred in
3.3%, 1.9% and 1.4% of patients, respectively.
"This is an important milestone
for TESARO, marking our second positive CHMP opinion for our
portfolio in 2017. We are rapidly globalizing the Company's mission
of providing transformative oncology therapies to those who need
them most," said Orlando Oliveira, Senior Vice President and
General Manager of TESARO International. "Upon final approval by
the EC, we intend to launch ZEJULA across multiple countries in
Europe where we already have an established, direct presence,
beginning in the fourth quarter."
About
Ovarian Cancer in Europe
Europe has one
of the highest incidences of ovarian cancer in the world with
approximately 45,000 women diagnosed there every year1,[2]. Ovarian
cancer affects approximately 1.3 in 10,000 people in the European
Union, where it is the sixth-most common cancer among women and the
fifth-most frequent cause of cancer death among women3,[4]. Despite
high initial response rates to platinum-based chemotherapy,
approximately 85% of women with advanced ovarian cancer will
experience a recurrence of the disease after first-line treatment.
The efficacy of chemotherapy also diminishes over time.
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 and follow us
on Twitter and LinkedIn.
About ZEJULA
(niraparib)
ZEJULA is an oral, once-daily
poly (ADP-ribose) polymerase (PARP) 1/2 inhibitor that is indicated
in the U.S. for the maintenance treatment of adult patients with
recurrent epithelial ovarian, fallopian tube, or primary peritoneal
cancer who are in a complete or partial response to platinum-based
chemotherapy. The National Comprehensive Cancer Network (NCCN)
added ZEJULA to the NCCN Clinical Practice Guidelines in Oncology
Ovarian Cancer version 1.2017-April 12, 2017-as maintenance therapy
for patients with platinum-sensitive disease who are in partial or
complete response after completion of two or more lines of
platinum-based chemotherapy. In preclinical studies, ZEJULA
concentrates in the tumor relative to plasma, delivering greater
than 90% durable inhibition of PARP 1/2 and a persistent antitumor
effect.
Forward
Looking Statements
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, risks associated with competition in the PARP market,
risks related to pricing and reimbursement, risks related to
manufacturing and supply, risks related to intellectual property,
and other risks and uncertainties that could affect the
availability or commercial potential of ZEJULA. 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, 2016 and Quarterly Report
on Form 10-Q for the quarter ended June 30, 2017.
_________________________
1 World
Cancer Research Fund
International. http://www.wcrf.org (Last accessed 14
September 2017)
2 EUCAN
(EU, EEA and
Switzerland). http://eco.iarc.fr/eucan/CancerOne.aspx?Cancer=27&Gender=2 (Last
accessed 14 September 2017)
3 EUCAN. http://eco.iarc.fr/eucan/CancerOne.aspx?Cancer=27&Gender=2
(Last accessed 14 September 2017)
4 CDC, https://www.cdc.gov/cancer/ovarian/statistics/index.htm (Last
accessed 14 September 2017)
Global Media
& Investor Contact:
Jennifer
Davis
Vice President, Corporate Communications & Investor
Relations
+1.781.325.1116 or jdavis@tesarobio.com
Ex-U.S. Media
Contact:
Shannon
Altimari
Head of Corporate Affairs, International
+41 (0) 41 588 08 68 or saltimari@tesarobio.com
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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