TESARO Announces Rolapitant Data Presentations at the 2016 MASCC/ISOO Annual Meeting on Supportive Care in Cancer
June 23 2016 - 6:30PM
TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical
company, today announced nine presentations of rolapitant data at
the 2016 MASCC/ISOO Annual Meeting on Supportive Care in Cancer,
June 23 to 25, 2016, in Adelaide, Australia.
“Delayed chemotherapy-induced nausea and vomiting
can be a debilitating side effect of chemotherapy. At this year’s
MASCC/ISOO Annual Meeting, which is the premier global event for
supportive care in cancer, we are pleased that data will be
presented that demonstrate the activity of rolapitant in patients
at high risk for CINV, including those who are receiving cisplatin-
and carboplatin-based chemotherapy for gynecologic and lung
cancers,” said Mary Lynne Hedley, Ph.D., President and COO of
TESARO. “With our Marketing Authorisation Application (MAA) for
oral rolapitant under review by the European Medicines Agency (EMA)
and our New Drug Application (NDA) for intravenous rolapitant under
review by the U.S. FDA, we look forward to globalizing our mission
of improving the lives of people bravely facing cancer.”
Please visit TESARO at Booth #3 for information
about VARUBI (rolapitant) and our pipeline.
Presentation Details:
Rolapitant for control of chemotherapy-induced
nausea and vomiting (CINV) in patients with gynecologic
cancerAbstract: MASCC-0318, Poster Presentation, Thursday, June 23,
2016Rolapitant for the prevention of nausea in patients receiving
moderately or highly emetogenic chemotherapyAbstract: MASCC-0322,
Poster Presentation, Thursday, June 23, 2016Rolapitant for
prevention of chemotherapy-induced nausea and vomiting (CINV) in
patients aged <65 versus ≥65 yearsAbstract: MASCC-0432, Poster
Presentation, Thursday, June 23, 2016Single ascending dose
pharmacokinetics of rolapitant administered intravenously at
supratherapeutic doses in healthy volunteersAbstract: MASCC-0489,
Poster Presentation, Thursday, June 23, 2016Effects of rolapitant
administered intravenously on the pharmacokinetics of cooperstown
cocktail (midazolam [CYP3A4], omeprazole [CYP2C19], warfarin
[CYP2C9], caffeine [CYP1A2], and dextromethorphan [CYP2D6]) in
healthy volunteersAbstract: MASCC-0492, Poster Presentation,
Thursday, June 23, 2016Effects of rolapitant administered
intravenously on the pharmacokinetics of digoxin (P-gp) and
sulfasalazine (BCRP) in healthy volunteersAbstract: MASCC-0494,
Poster Presentation, Thursday, June 23, 2016A single-dose
bioequivalence study of rolapitant following oral and intravenous
administration in healthy volunteersAbstract: MASCC-0485, Oral
Poster Presentation, Friday, June 24, 2016 from 2:00 PM to 3:30
PMRolapitant for control of chemotherapy-induced nausea and
vomiting (CINV) in patients with lung cancer Abstract: MASCC-0321,
Oral Proffered Presentation, Hall M, Saturday, June 25, 2016 from
11:00 AM to 12:30 PM
Rolapitant for prevention of chemotherapy-induced
nausea and vomiting (CINV) in patients with breast cancerAbstract:
MASCC-0316, Oral Proffered Presentation, Hall M, Saturday, June 25,
2016 from 11:00 AM to 12:30 PM
About VARUBI® (Rolapitant) VARUBI
is a substance P/neurokinin-1 (NK-1) receptor antagonist indicated
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 the U.S. prescribing information,
including additional important safety information, available at
www.varubirx.com.
An intravenous formulation of rolapitant is
currently under review by the FDA, with a target action date under
the Prescription Drug User Fee Act (PDUFA) of January 11, 2017. An
MAA for oral rolapitant is currently under review by the EMA.
TESARO licensed exclusive rights for the development, manufacture,
commercialization, and distribution of VARUBI (rolapitant) from
OPKO Health, Inc.
About TESAROTESARO is an
oncology-focused biopharmaceutical company dedicated to improving
the lives of cancer patients by acquiring, developing and
commercializing safer and more effective therapeutics. 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.
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, the uncertainties inherent in expectations with
respect to regulatory submissions and approvals, 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 March 31, 2016.
Investor/Media Contact:
Jennifer Davis
Sr. Director, Corporate Development & Investor Relations
+1.781.325.1116 or jdavis@tesarobio.com
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