TESARO Receives Positive CHMP Opinion for ZEJULA®
(Thomson Reuters ONE) -
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 year(1)(,[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 women(3)(,[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(at)tesarobio.com
Ex-U.S. Media Contact:
Shannon Altimari
Head of Corporate Affairs, International
+41 (0) 41 588 08 68 or saltimari(at)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
Unternehmensinformation / Kurzprofil:
" alt="Far Resources Receives Drill Permit and Immediately Mobilizes Crew to Zoro Lithium Property">
Datum: 15.09.2017 - 14:36 Uhr
Sprache: Deutsch
News-ID 560096
Anzahl Zeichen: 9374
contact information:
Town:
Massachusetts
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 341 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"TESARO Receives Positive CHMP Opinion for ZEJULA®"
steht unter der journalistisch-redaktionellen Verantwortung von
TESARO, Inc. (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
