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
EuropeEurope 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 TESAROTESARO 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 StatementsTo
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
Tesaro, Inc. (NASDAQ:TSRO)
Historical Stock Chart
From Apr 2024 to May 2024
Tesaro, Inc. (NASDAQ:TSRO)
Historical Stock Chart
From May 2023 to May 2024