TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical
company, today announced that the European Commission (EC) has
approved VARUBY
® (oral rolapitant tablets) for the
prevention of delayed nausea and vomiting associated with highly
and moderately emetogenic cancer chemotherapy in adults.
Chemotherapy-induced nausea and vomiting (CINV) is a frequent and
debilitating, yet often preventable, side effect of chemotherapy.
VARUBY is a selective and competitive antagonist
of human substance P/neurokinin 1 (NK-1) receptors that is rapidly
absorbed and slowly eliminated, with a plasma half-life of seven
days. A single 180 milligram dose (two tablets) of VARUBY is to be
administered within two hours prior to initiation of each
chemotherapy cycle, but at no less than 2‑week intervals, as part
of combination therapy. Results from three global Phase 3
trials of VARUBY demonstrated a significant reduction in episodes
of vomiting or use of rescue medication during the 25 to 120 hour
period following administration of emetogenic chemotherapy,
including cisplatin, carboplatin and
anthracycline/cyclophosphamide-based regimens. In addition,
patients who received VARUBY reported experiencing less nausea
that interfered with normal daily life and fewer episodes of
vomiting over multiple cycles of chemotherapy. Results of each of
the three Phase 3 studies were published in The Lancet Oncology in
August 2015.i,ii
“With more than half of patients treated with
emetogenic chemotherapy experiencing delayed nausea and vomiting,
the approval of VARUBY will give physicians in Europe a new option
to help prevent this serious side effect,” said Orlando Oliveira,
Senior Vice President and General Manager of TESARO
International. “This approval represents an important
milestone in TESARO’s international expansion. With TESARO
operating in 17 European countries, we look forward to bringing
this important medicine to patients as quickly as possible.”
“While important progress in the treatment and
prevention of delayed CINV has been made, nausea and vomiting
continue to be two of the most common and distressing side effects
of cancer chemotherapy,” said Florian Scotté, M.D., Ph.D., Head of
the Functional Unit of Supportive Care, Department of Medical
Oncology at Hôpital Européen Georges Pompidou, Paris, France.
“Adding an NK-1 receptor antagonist such as VARUBY, which has a
7-day half-life and greater than 90% receptor occupancy in the
cortical regions of the brain five days after dosing, can provide
enhanced protection from delayed CINV, which can last for several
days.”
The centralised marketing authorisation applies
to all 28 European Union (EU) member states as well as in the
European Economic Area (EEA) countries of Iceland, Lichtenstein and
Norway. TESARO is working with the appropriate national authorities
in the European countries to support reimbursement and availability
of VARUBY to ensure that patients who may benefit from VARUBY have
access to it.
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®.
About Chemotherapy-Induced Nausea and
Vomiting (CINV)Chemotherapy-induced nausea and vomiting is
a debilitating, yet often preventable, side effect of chemotherapy.
Up to 50% of patients undergoing highly or moderately emetogenic
chemotherapy experience delayed CINV (>24 to 120 hours post
chemotherapy)—even when prescribed a 5-HT3 receptor antagonist
and a corticosteroid. Blocking both 5-HT3 and NK-1 receptors
has been shown to offer better control of nausea and vomiting than
inhibiting 5-HT3 receptors alone. Adding a single dose of
VARUBY® to an antiemetic regimen, including a 5-HT3 receptor
antagonist and corticosteroid, within two hours prior to each
chemotherapy cycle as part of combination therapy further improves
prevention of delayed CINV.
About the VARUBY (Oral Rolapitant
Tablets) Clinical ProgramThe efficacy of VARUBY was
established in multiple randomized, well-controlled, international,
blinded clinical trials that enrolled more than 2,500 patients.
VARUBY, when administered in combination with a 5-HT3 receptor
antagonist and dexamethasone, was superior to a 5-HT3 receptor
antagonist and dexamethasone in preventing CINV in patients
receiving either moderately or highly emetogenic chemotherapy.
The clinical profile of VARUBY in
cisplatin-based highly emetogenic chemotherapy (HEC) was confirmed
in two identical Phase 3 studies: HEC1 and HEC2. Both trials met
their primary endpoint of complete response (CR), and demonstrated
statistical superiority of rolapitant 180 mg compared to active
control (5-HT3 receptor antagonist plus dexamethasone) in the
delayed phase (25-120 hours) of CINV. In HEC1, 264 patients
received rolapitant 180 mg and 262 received control. The proportion
of patients achieving a CR was 72.7% vs. 58.4% (p=< 0.001). In
HEC2, 271 patients received rolapitant and 273 received control.
The proportion of patients achieving a CR was 70.1% vs. 61.9%
(p=0.043). The most common adverse reactions (≥3%) among patients
receiving cisplatin-based chemotherapy were neutropenia (9%
rolapitant vs. 8% control), hiccups (5% vs. 4%), and abdominal pain
(3% vs. 2%).
A Phase 3 trial was also conducted to evaluate
rolapitant 180 mg compared to active control in 1,332 patients
receiving moderately emetogenic chemotherapy regimens, including
anthracycline/cyclophosphamide combinations, carboplatin,
irinotecan, pemetrexed, oxaliplatin, and doxorubicin. This trial
met its primary endpoint of CR, and demonstrated statistical
superiority of rolapitant 180 mg compared to active control (5-HT3
receptor antagonist plus dexamethasone) in the delayed phase of
CINV. The proportion of patients achieving a CR was 71.3% vs 61.6%
(p= < 0.001). The most common adverse reactions (≥3%) among
patients receiving these chemotherapies were decreased appetite (9%
rolapitant vs. 7% control), neutropenia (7% vs. 6%), dizziness (6%
vs. 4%), dyspepsia (4% vs. 2%), urinary tract infection (4% vs.
3%), stomatitis (4% vs. 2%), and anemia (3% vs. 2%).
About VARUBY® (oral
rolapitant tablets)VARUBY is a substance P/neurokinin-1
(NK-1) receptor antagonist that is approved in the European Union
for use in combination with other antiemetic agents in adults for
the prevention of delayed nausea and vomiting associated with
highly and moderately emetogenic cancer chemotherapy in adults.
VARUBY is contraindicated in combination with St John’s wort. Each
tablet contains 90 mg of rolapitant (as hydrochloride monohydrate).
The inhibitory effect of a single dose of VARUBI/VARUBY on CYP2D6
lasts at least seven days and may last longer. VARUBI/VARUBY is not
recommended in patients who require chronic administration of
strong or moderate enzyme inducers. Please see full product
information for more details.
VARUBI (rolapitant) is also approved in the
United States in combination with other antiemetic agents 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. Please
see additional important safety information and full prescribing
information at www.varubirx.com.
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.
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 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 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, 2016.
_____________________________
i Rapoport, BL et al. Safety and efficacy of rolapitant for
prevention of chemotherapy-induced nausea and vomiting after
administration of cisplatin-based highly emetogenic chemotherapy in
patients with cancer: two randomised, active-controlled,
double-blind, phase 3 trials. The Lancet Oncology, Vol. 16, No. 9,
p1079–1089.
ii Schwartzberg LS et al. Safety and efficacy of rolapitant
for prevention of chemotherapy-induced nausea and vomiting after
administration of moderately emetogenic chemotherapy or
anthracycline and cyclophosphamide regimens in patients with
cancer: a randomised, active-controlled, double-blind, phase 3
trial. The Lancet Oncology, Vol. 16, No. 9, p1071–1078.
Investor/Media Contact:
Jennifer Davis
Vice President, Corporate Affairs & Investor Relations
+1.781.325.1116 or jdavis@tesarobio.com
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