- VARUBY
provides protection for delayed chemotherapy-induced nausea and
vomiting (CINV) with a single dose as part of an antiemetic
regimen
- Up to 50% of
patients undergoing highly or moderately emetogenic chemotherapy
experience delayed CINV even when prescribed a 5-HT3 receptor
antagonist and corticosteroid
- Approval based
upon results of three Phase 3 trials of patients receiving
emetogenic chemotherapy, including cisplatin, carboplatin and
anthracycline/cyclophosphamide-based regimens
- Commercial
launches to begin on a country-by-country basis in Europe by end of
Q2
WALTHAM, Mass. and ZUG,
Switzerland, April 26, 2017 (GLOBE NEWSWIRE) -- 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
Program
The 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 (greater than or equal
to 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
(greater than or equal to 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
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.
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.