TESARO Receives Positive CHMP Opinion for VARUBY®
(Thomson Reuters ONE) -
WALTHAM, Mass., Feb. 27, 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 rendered a positive opinion for the Company's marketing authorization
application (MAA) for VARUBY(®) (oral rolapitant tablets) for the prevention of
delayed nausea and vomiting associated with highly and moderately emetogenic
cancer chemotherapy in adults.
The VARUBY MAA submission was supported by data from four controlled studies
covering a spectrum of patients receiving emetogenic chemotherapy. One study
enrolled patients receiving moderately emetogenic chemotherapy (MEC), and three
studies enrolled patients receiving cisplatin-based highly emetogenic
chemotherapy (HEC). The top-line results of each of the three Phase 3 studies
of rolapitant were presented in detail at the American Society for Clinical
Oncology (ASCO) annual meeting in June 2014. Oral rolapitant was approved by the
U.S. Food and Drug Administration on September 1, 2015 and is marketed by TESARO
in the United States under the brand name VARUBI(®).
"Chemotherapy-induced nausea and vomiting (CINV) remains a significant unmet
need, with more than half of patients treated with emetogenic chemotherapy
experiencing this debilitating side effect for up to five days," said Mary Lynne
Hedley, Ph.D., President and COO of TESARO. "The positive CHMP opinion for
VARUBY is an important milestone for the Company. VARUBY is positioned to be
TESARO's first commercial product in Europe, and we look forward to bringing
this important medicine to patients as quickly as possible."
"TESARO has an exciting pipeline of oncology therapeutics, and with the positive
CHMP opinion for VARUBY today and our planned product launches in Europe this
year, we are globalizing our mission of providing transformative therapies to
people bravely facing cancer," said Orlando Oliveira, Senior Vice President and
General Manager of TESARO International. "Following today's positive CHMP
opinion, and subject to final approval and completion of pricing and
reimbursement discussions, TESARO plans to launch VARUBY in Europe beginning in
the first half of 2017, on a country-by-country basis. Our international
organization now spans 17 European countries and is well prepared to make this
treatment available in each country as soon as possible."
About VARUBI(® )(Rolapitant)
VARUBI is a substance P/neurokinin-1 (NK-1) receptor antagonist that is approved
in the United States for use in combination with other antiemetic agents in
adults for the prevention of delayed nausea and vomiting associated with initial
and repeat courses of emetogenic cancer chemotherapy, including, but not limited
to, highly emetogenic chemotherapy. VARUBI is contraindicated in patients
receiving thioridazine, a CYP2D6 substrate. The inhibitory effect of a single
dose of VARUBI on CYP2D6 lasts at least seven days and may last longer. Avoid
use of pimozide; monitor for adverse events if concomitant use with other CYP2D6
substrates with a narrow therapeutic index cannot be avoided. Please see full
prescribing information, including additional important safety information,
available at www.varubirx.com.
Rolapitant will be marked under the trade name VARUBY in Europe.
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.
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. Examples of forward-looking
statements contained in this press release include, among others, statements
regarding TESARO's plans to launch two products in Europe in 2017, including
VARUBY in the first half of 2017. Forward-looking statements in this release
involve substantial risks and uncertainties that could cause our future results,
performance, or achievements, including the potential approval and launch of
VARUBY in Europe, to differ significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include, among others,
the uncertainties inherent in drug development and the execution and completion
of clinical trials, uncertainties surrounding our ongoing discussions with and
potential actions by the EMA, risks related to manufacturing and supply, and
other matters that could affect the ultimate approval, availability or
commercial potential of VARUBY. 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 Quarterly Report on Form 10-Q for the quarter ended
September 30, 2016.
Investor/Media Contact:
Jennifer Davis
Vice President, Corporate Affairs & Investor Relations
+1.781.325.1116 or jdavis(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:
Datum: 27.02.2017 - 08:00 Uhr
Sprache: Deutsch
News-ID 526610
Anzahl Zeichen: 6704
contact information:
Town:
Massachusetts
Kategorie:
Business News
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