TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical
company, today announced that VARUBI® (rolapitant) IV, is now
available in the United States. The U.S. Food and Drug
Administration (FDA) approved VARUBI injectable emulsion on October
25, 2017, 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.
“The U.S. launch of VARUBI IV reinforces
TESARO’s ongoing commitment to developing and commercializing
therapies for people facing cancer,” said Mary Lynne Hedley, Ph.D.,
President and COO of TESARO. “VARUBI IV offers healthcare providers
an easy-to-use option for the prevention of delayed CINV. The
ready-to-use, single-dose vial does not require saline and
eliminates the need for reconstitution and mixing, and can be
easily adopted into existing practice patterns. We are confident
that we have the right team and strategy in place to ensure this
product is made available in the clinic or hospital to all patients
in need.”
VARUBI is a highly selective and potent
antagonist of human substance P/neurokinin 1 (NK-1) receptors,
which play an important role in the delayed phase of
chemotherapy-induced nausea and vomiting (CINV). With a long plasma
half-life of approximately seven days, a single dose of VARUBI, as
part of an antiemetic regimen, significantly improved complete
response (CR) rates in the delayed phase of CINV. Results from
three Phase 3 trials of VARUBI oral tablets demonstrated a
significant reduction in episodes of vomiting or use of rescue
medication during the 25- to 120-hour period following
administration of highly emetogenic and moderately emetogenic
chemotherapy regimens. As a result, patients may be protected from
nausea and vomiting during their most vulnerable time, in the days
following chemotherapy. In addition, patients who received
VARUBI reported experiencing less nausea that interfered with
normal daily life and fewer episodes of vomiting or retching over
multiple cycles of chemotherapy. Results from a bioequivalence
trial demonstrated comparability of the IV and oral formulations of
VARUBI.
VARUBI IV is supplied in ready-to-use vials and
does not require refrigerated storage or mixing. As a result,
utilization in busy chemotherapy clinics is straightforward and
easily adopted into existing practice patterns for administration
of antiemetic regimens associated with emetogenic chemotherapy.
VARUBI IV is to be administered up to two hours before chemotherapy
administration in combination with a 5-HT3 receptor antagonist and
dexamethasone. No dosage adjustment is required for dexamethasone,
a CYP3A4 substrate, and VARUBI is the first intravenously
administered NK-1 receptor antagonist approved by the FDA that does
not contain polysorbate 80.
“As an oncology nurse, I see the pressing need
for a product like VARUBI IV for our patients,” said Robin
Wachsman, RN, BSN, CCRN, OCN, BCN, Director of Women’s Oncology
Services, Baptist Medical Group, Memphis, TN. “With a
polysorbate 80-free formulation and a long half-life, provided in a
ready-to-use vial that does not require refrigeration, VARUBI IV
will be a very welcomed addition to our anti-emetic regimen.”
“Severe shortages of intravenous fluids continue
to plague practices across the country,” said Erin R. Fox, PharmD,
BCPS, Senior Director, Drug Information at University of Utah
Health. “Medications that are available in ready-to-use vials offer
organizations a potential option to overcome this challenge and
meet the needs of their patients.”
The full prescribing information for VARUBI IV
will be available at www.VarubiRx.com.
TOGETHER with TESARO™TOGETHER
with TESARO™ is a patient resource program dedicated to
supporting people living with cancer. The program assists
with access issues, so that patients with cancer can be free
to focus on treatment goals and simply living life. It
provides a full suite of services to meet each patient’s needs
and individual experience. A team of access and
affordability experts is available to
help oncology practices and patients gain access
to the medication they require. TOGETHER with TESARO
will continue to evolve and grow to meet provider
and patient needs.
For more information, please visit
www.togetherwithtesaro.com or call 1-844-2TESARO
(1-844-283-7276).
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 (25 to 120 hours post
chemotherapy) — even when prescribed a 5-HT3 receptor antagonist
and 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 VARUBI to
an antiemetic regimen, including a 5-HT3 receptor antagonist and
corticosteroid, further improves prevention of CINV in the delayed
phase following chemotherapy.
About the VARUBI (Rolapitant) Clinical
ProgramThe superior efficacy of VARUBI was established in
multiple global randomized, well-controlled, double-blinded
clinical trials that enrolled more than 2,500 patients. VARUBI,
when administered in combination with a 5-HT3 receptor antagonist
and dexamethasone, was superior to a 5-HT3 receptor antagonist and
dexamethasone alone in preventing delayed CINV in patients
receiving either moderately or highly emetogenic chemotherapy.
The clinical profile of VARUBI 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 oral) 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 and 262 received active 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 active
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% VARUBI 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 oral) 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 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%
VARUBI 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%).
Primary data from the three Phase 3 studies have
been published in Lancet Oncology, the analysis of the non-AC MEC
population was presented at the 2015 annual meeting of the
Multinational Association for Supportive Care in Cancer, and
commentary has been provided in Nature Reviews Clinical
Oncology.
In addition to the Phase 3 program, a
bioequivalence study was conducted in healthy volunteers to compare
the exposure of the 166.5 milligram dose of IV rolapitant to the
exposure of a 180 milligram dose of oral rolapitant. Study
participants were randomized to receive a single dose of either
166.5 milligrams of intravenous rolapitant administered over 30
minutes (n=61) or 180 milligrams of oral rolapitant (n=62). The
primary endpoint of this pivotal study was bioequivalence, defined
by estimating whether the 90% confidence intervals (CI) for the
ratio of the area under the curves (AUCs) of the two formulations
are entirely included within the acceptance range of 80% to 125%.
Safety and tolerability were also assessed for both formulations.
The safety profile was consistent with previous clinical trials
with oral rolapitant, except for infusion-site reactions observed
with the IV formulation.
VARUBI Additional Safety
InformationVARUBI is contraindicated in patients taking
CYP2D6 substrates with a narrow therapeutic index, such as
thioridazine and pimozide. VARUBI can significantly increase the
plasma concentrations of thioridazine and pimozide, which may
result in QT prolongation and Torsades de Pointes.
VARUBI is a moderate inhibitor of CYP2D6 and
significantly increases the plasma concentrations of CYP2D6
substrates for at least 28 days, with inhibitory effects expected
to persist for an unknown duration. Monitor for adverse
reactions when VARUBI is coadministered with CYP2D6 substrates
without a narrow therapeutic index (avoid coadministration with
CYP2D6 substrates with a narrow therapeutic index, thioridazine and
pimozide; see Contraindication).
In clinical trials, the most common adverse
reactions reported were neutropenia, hiccups, decreased appetite
and dizziness. IV administration of VARUBI was also
associated with infusion-related symptoms (e.g., sensation of
warmth, abdominal pain, dizziness, and paresthesia).
Avoid use of VARUBI in patients who require
chronic administration of strong CYP3A4 inducers (e.g., rifampin),
as significantly reduced plasma concentrations of VARUBI can
decrease the efficacy of VARUBI.
VARUBI, administered as an IV or oral
medication, is not an inhibitor of CYP3A4 and no dose adjustment is
required for co-administered CYP3A4 substrates, including
dexamethasone.
VARUBI IV did not inhibit breast cancer
resistance protein (BCRP) and P-glycoprotein (P-gp). VARUBI
given as an oral dose is an inhibitor of breast cancer resistance
protein (BCRP) and P-glycoprotein (P-gp). Increased plasma
concentrations of BCRP substrates (e.g., methotrexate, topotecan,
or irinotecan) and P-gp substrates (e.g., digoxin) with a narrow
therapeutic index may result in potential adverse reactions.
Monitor digoxin concentrations with concomitant use of VARUBI, and
adjust the dosage as needed to maintain therapeutic
concentrations.
Monitor INR and prothrombin time and adjust the
dosage of warfarin, as needed, to maintain target INR.
VARUBI is available by prescription only. Please
see full prescribing information, including additional important
safety information, available 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.
Investor/Media ContactJennifer
DavisVice President, Corporate Communications & Investor
Relations+1.781.325.1116 or jdavis@tesarobio.com
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 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
manufacturing and supply, risks related to competition, and other
matters that could affect the availability or commercial potential
of VARUBI IV. 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
September 30, 2017.
A photo accompanying this announcement is available at
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A video accompanying this announcement is available
athttp://www.globenewswire.com/NewsRoom/AttachmentNg/e73bcfbf-6c28-4180-99f7-73b06f3e062f
An infographic accompanying this announcement is available at
http://www.globenewswire.com/NewsRoom/AttachmentNg/399934cc-fb8d-4cd7-a768-f64a4fd82645
A video accompanying this announcement is available
athttp://www.globenewswire.com/NewsRoom/AttachmentNg/4e6bafa2-368b-4212-9816-3f1d020054c9
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