Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and
Drug Administration has approved a new indication expanding the use
of SUTENT® (sunitinib malate) to include the adjuvant treatment of
adult patients at high risk of recurrent renal cell carcinoma (RCC)
following nephrectomy (surgical removal of the cancerous kidney).
The approval was based on results from the S-TRAC trial that
demonstrated a significant reduction in the risk of a disease-free
survival (DFS) event (defined as the interval between randomization
and tumor recurrence, or secondary primary cancer or death from any
cause) for patients at high risk of RCC recurrence who received
SUTENT compared to placebo in the adjuvant setting.
SUTENT has been a standard of care for the treatment of advanced
RCC since it was approved more than a decade ago, and is now the
first approved adjuvant treatment option for certain patients at
high risk of recurrent RCC - the most common type of kidney cancer.
The current treatment approach for RCC patients is surgery followed
by observation, which is suboptimal for patients at high risk of
recurrence.
“Today’s approval marks an important step forward for the
treatment of adult patients who are at high risk of their renal
cell carcinoma returning after surgery,” said Liz Barrett, global
president and general manager, Pfizer Oncology. “Pfizer has been
dedicated to advancing the science of RCC treatment for over a
decade, and we are pleased to see this commitment continue to
translate into meaningful options for patients.”
The S-TRAC trial was a multicenter, international, randomized,
double-blind, placebo-controlled Phase 3 trial of SUTENT versus
placebo in 615 patients with clear cell histology and high risk of
recurrent RCC following nephrectomy. The study met its primary
endpoint of improving DFS and the results were published by The New
England Journal of Medicine in October 2016.
“Some patients who have undergone surgery for locally advanced
RCC are at high risk of recurrence and often fear their disease
returning,” said Daniel George, MD, study investigator and medical
oncologist at Duke University Medical Center. “This adjuvant
therapy is the first-of-its-kind and a remarkable clinical
development for these patients who before today, have been
restricted to a wait and see approach.”
In the S-TRAC trial, the Hazard Ratio (HR) was 0.76 (95% CI:
0.59, 0.98) with a 2-sided p-value=0.03 in favor of SUTENT,
representing a statistically significant 24% relative reduction in
the risk of a DFS event. The median DFS was 6.8 years (95% CI: 5.8,
not reached [NR]) in the SUTENT arm compared with 5.6 years (95%
CI: 3.8, 6.6) in the placebo arm. At five years, the DFS rate for
patients receiving SUTENT was 59.3% and 51.3% for placebo. This
represents a persistent 8% absolute benefit.
No new safety signals were identified in the S-TRAC trial. The
most common adverse reactions occurring in ≥20% of patients
receiving SUTENT for adjuvant treatment of RCC (all grades) were
mucositis/stomatitis (61%), fatigue/asthenia (57%), diarrhea (57%),
hand-foot syndrome (50%), hypertension (39%), altered taste (38%),
nausea (34%), dyspepsia (27%), abdominal pain (25%), rash (24%),
hypothyroidism/TSH increased (24%), bleeding events, all sites
(24%), and hair color changes (22%). The prescribing information
for SUTENT also includes a boxed warning for hepatotoxicity and
notes the following warnings and precautions: cardiovascular
events; QT Interval Prolongation and Torsades de Pointes;
hypertension; hemorrhagic events and viscus perforation; Tumor
Lysis Syndrome (TLS); thrombotic microangiopathy (TMA);
proteinuria; dermatologic toxicities; thyroid dysfunction;
hypoglycemia; osteonecrosis of the jaw (ONJ); wound healing; and
embryo-fetal toxicity. For more information, including Boxed
Warning, please see the Important Safety Information for SUTENT
below.
SUTENT Important Safety Information
Hepatotoxicity has been observed in clinical trials and
postmarketing experience. Hepatotoxicity may be severe, and in some
cases fatal. Monitor hepatic function and interrupt, reduce, or
discontinue dosing as recommended. Fatal liver failure has been
observed. Monitor liver function tests before initiation of
treatment, during each cycle of treatment, and as clinically
indicated. Interrupt SUTENT for Grade 3 or 4 drug-related hepatic
adverse reactions and discontinue if there is no resolution. Do not
restart SUTENT if patients subsequently experience severe changes
in liver function tests or have signs and symptoms of liver
failure.
Cardiovascular events, including myocardial ischemia,
myocardial infarction, left ventricular ejection fraction declines
to below the lower limit of normal and cardiac failure including
death have occurred. Monitor patients for signs and symptoms of
congestive heart failure. Discontinue SUTENT for clinical
manifestations of congestive heart failure. In patients without
cardiac risk factors, a baseline evaluation of ejection fraction
should be considered. Baseline and periodic evaluations of left
ventricular ejection fraction should also be considered while these
patients are receiving SUTENT.
SUTENT can cause QT Prolongation in a dose-dependent
manner, which may lead to an increased risk for ventricular
arrhythmias including Torsades de Pointes, which has been
seen in <0.1% of patients. Monitor patients that are at a higher
risk for developing QT interval prolongation, including those with
a history of QT interval prolongation, patients who are taking
antiarrhythmics, or patients with relevant pre-existing cardiac
disease, bradycardia, or electrolyte disturbances. Consider
monitoring of electrocardiograms and electrolytes. Concomitant
treatment with strong CYP3A4 inhibitors may increase sunitinib
plasma concentrations and dose reduction of SUTENT should be
considered.
Hypertension may occur. Monitor blood pressure and treat
as needed with standard antihypertensive therapy. In cases of
severe hypertension, temporary suspension of SUTENT is recommended
until hypertension is controlled.
Hemorrhagic events, including tumor-related hemorrhage,
and viscus perforation (both with fatal events) have occurred.
These events may occur suddenly, and in the case of pulmonary
tumors, may present as severe and life-threatening hemoptysis or
pulmonary hemorrhage. Perform serial complete blood counts (CBCs)
and physical examinations.
Cases of tumor lysis syndrome (TLS) (some fatal) have
been reported. Patients generally at risk of TLS are those with
high tumor burden prior to treatment. Monitor these patients
closely and treat as clinically indicated.
Thrombotic microangiopathy (TMA), including thrombotic
thrombocytopenic purpura and hemolytic uremic syndrome, sometimes
leading to renal failure or a fatal outcome, has been reported in
patients who received SUTENT as monotherapy and in combination with
bevacizumab. Discontinue SUTENT in patients developing TMA.
Reversal of the effects of TMA has been observed after treatment
was discontinued.
Proteinuria and nephrotic syndrome have been reported.
Some of these cases have resulted in renal failure and fatal
outcomes. Monitor patients for the development or worsening of
proteinuria. Perform baseline and periodic urinalysis during
treatment, with follow-up measurement of 24-hour urine protein as
clinically indicated. Interrupt treatment for 24-hour urine protein
≥3 grams. Discontinue for repeat episodes of protein ≥3 grams
despite dose reductions or nephrotic syndrome.
Dermatologic toxicities: Severe cutaneous reactions have
been reported, including cases of necrotizing fasciitis, erythema
multiforme (EM), Stevens-Johnson syndrome (SJS), and toxic
epidermal necrolysis (TEN), some of which were fatal. If signs or
symptoms of EM, SJS, or TEN are present, discontinue SUTENT
treatment. If a diagnosis of SJS or TEN is suspected, treatment
must not be re-started.
Necrotizing fasciitis, including fatal cases, has been
reported, including of the perineum and secondary to fistula
formation. Discontinue SUTENT in patients who develop necrotizing
fasciitis.
Thyroid dysfunction may occur. Monitor thyroid function
in patients with signs and/or symptoms suggestive of thyroid
dysfunction, including hypothyroidism, hyperthyroidism, and
thyroiditis, and treat per standard medical practice.
Hypoglycemia may occur. SUTENT can result in symptomatic
hypoglycemia, which may lead to a loss of consciousness or require
hospitalization. Reductions in blood glucose levels may be worse in
patients with diabetes. Check blood glucose levels regularly during
and after discontinuation of treatment with SUTENT. Assess if
antidiabetic drug dosage needs to be adjusted to minimize the risk
of hypoglycemia.
Osteonecrosis of the jaw (ONJ) has been reported.
Consider preventive dentistry prior to treatment with SUTENT. If
possible, avoid invasive dental procedures, particularly in
patients receiving intravenous bisphosphonate therapy.
Impaired wound healing has occurred with SUTENT.
Temporary interruption of therapy with SUTENT is recommended in
patients undergoing major surgical procedures. There is limited
clinical experience regarding the timing of reinitiation of therapy
following major surgical intervention. Therefore, the decision to
resume SUTENT therapy following a major surgical intervention
should be based upon clinical judgment of recovery from
surgery.
Embryo fetal toxicity and reproductive potential
Females - SUTENT can cause fetal harm when administered to
pregnant women. Advise pregnant women of the potential risk to a
fetus. Advise females of reproductive potential to use effective
contraception during treatment with SUTENT and for 4 weeks
following the final dose
Males - Based on findings in animal reproduction studies, advise
male patients with female partners of reproductive potential to use
effective contraception during treatment with SUTENT and for
7 weeks after the last dose
Male and female infertility - based on findings in animals, male
and female fertility may be compromised by treatment with
SUTENT
Lactation: Because of the potential for serious adverse
reactions in breastfed infants from SUTENT, advise a lactating
woman not to breastfeed during treatment with SUTENT and for at
least 4 weeks after the last dose.
Venous thromboembolic events: In patients treated with
SUTENT (N=7527) for GIST, advanced RCC, adjuvant treatment of RCC
and pNET, 3.5% of patients experienced a venous thromboembolic
event; 2.2% Grade 3-4.
There have been (<1%) reports, some fatal, of subjects
presenting with seizures and radiological evidence of reversible
posterior leukoencephalopathy syndrome (RPLS). Patients with
seizures and signs/symptoms consistent with RPLS, such as
hypertension, headache, decreased alertness, altered mental
functioning, and visual loss, including cortical blindness, should
be controlled with medical management including control of
hypertension. Temporary suspension of SUTENT is recommended;
following resolution, treatment may be resumed at the discretion of
the treating healthcare provider.
Pancreatic function: In a trial of patients receiving
adjuvant treatment for RCC, 1 patient (<1%) on SUTENT and none
on placebo experienced pancreatitis.
CYP3A4 inhibitors and inducers: Dose adjustments are
recommended when SUTENT is administered with CYP3A4 inhibitors or
inducers. During treatment with SUTENT, patients should not drink
grapefruit juice, eat grapefruit, or take St. John's Wort.
Most common ARs & most common grade 3/4 ARs (adjuvant
RCC): The most common ARs reported in ≥20% of patients
receiving SUTENT for adjuvant treatment of RCC and more commonly
than in patients given placebo (all grades, vs placebo) were
mucositis/stomatitis (61% vs 15%), diarrhea (57% vs 22%),
fatigue/asthenia (57% vs 34%), hand-foot syndrome (50% vs 10%),
hypertension (39% vs 14%), altered taste (38% vs 6%), nausea (34%
vs 15%), dyspepsia (27% vs 7%), abdominal pain (25% vs 9%),
hypothyroidism/TSH increased (24% vs 4%), rash (24% vs 12%), hair
color changes (22% vs 2%). The most common grade 3/4 ARs reported
in ≥5% of patients receiving SUTENT for adjuvant treatment of RCC
and more commonly than in patients given placebo (vs placebo) were
hand-foot syndrome (16% vs <1%), fatigue/asthenia (8% vs 2%),
mucositis/stomatitis (6% vs 0%), and hypertension (8% vs 1%).
Most common grade 3/4 lab abnormalities (adjuvant RCC):
The most common grade 3/4 lab abnormalities (occurring in ≥ 2% of
patients receiving SUTENT) included neutropenia (13%),
thrombocytopenia (5%), leukopenia (3%), lymphopenia (3%), elevated
alanine aminotransferase (2%), elevated aspartate aminotransferase
(2%), hyperglycemia (2%), and hyperkalemia (2%).
Most common ARs & most common grade 3/4 ARs
(advanced RCC): The most common ARs reported in ≥20% of
patients receiving SUTENT for treatment-naïve metastatic RCC (all
grades, vs IFNα) were diarrhea (66% vs 21%), fatigue (62% vs 56%),
nausea (58% vs 41%), anorexia (48% vs 42%), altered taste (47% vs
15%), mucositis/stomatitis (47% vs 5%), pain in extremity/limb
discomfort (40% vs 30%), vomiting (39% vs 17%), bleeding, all sites
(37% vs 10%), hypertension (34% vs 4%), dyspepsia (34% vs 4%),
arthralgia (30% vs 19%), abdominal pain (30% vs 12%), rash (29% vs
11%), hand-foot syndrome (29% vs 1%), back pain (28% vs 14%), cough
(27% vs 14%), asthenia (26% vs 22%), dyspnea (26% vs 20%), skin
discoloration/yellow skin (25% vs 0%), peripheral edema (24% vs
5%), headache (23% vs 19%), constipation (23% vs 14%), dry skin
(23% vs 7%), fever (22% vs 37%), and hair color changes (20% vs
<1%). The most common grade 3/4 ARs reported in ≥5% of patients
with RCC receiving SUTENT (vs IFNα) were fatigue (15% vs 15%),
hypertension (13% vs <1%), asthenia (11% vs 6%), diarrhea (10%
vs <1%), hand-foot syndrome (8% vs 0%), dyspnea (6% vs 4%),
nausea (6% vs 2%), back pain (5% vs 2%), pain in extremity/limb
discomfort (5% vs 2%), vomiting (5% vs 1%), and abdominal pain (5%
vs 1%).
Most common grade 3/4 lab abnormalities (advanced RCC):
The most common grade 3/4 lab abnormalities (occurring in ≥5% of
patients with RCC receiving SUTENT vs IFNα) included lymphocytes
(18% vs 26%), lipase (18% vs 8%), neutrophils (17% vs 9%), uric
acid (14% vs 8%), platelets (9% vs 1%), hemoglobin (8% vs 5%),
sodium decreased (8% vs 4%), leukocytes (8% vs 2%), glucose
increased (6% vs 6%), phosphorus (6% vs 6%), and amylase (6% vs
3%).
Please see full Prescribing Information, including
BOXED WARNING and Medication Guide, for SUTENT® (sunitinib malate)
at www.SUTENT.com.
About Renal Cell Carcinoma (RCC)
Each year, approximately 304,000 new cases of kidney cancer are
diagnosed worldwide, representing approximately 2-3 percent of all
cancers.1,2,3 Renal cell carcinoma (RCC) is the most common type of
kidney cancer, accounting for around 90 percent of cases.4
Approximately 75 percent of patients with clear cell RCC are
non-metastatic, and 70-80 percent will have a nephrectomy with
curative intent, or surgical removal of the tumor.5 Patients at
high risk of recurrence represent approximately 15 percent of all
patients with primary resected RCC and approximately 60 percent of
these patients will recur and develop metastatic disease within
five years.6
About SUTENT® (sunitinib malate)
Sunitinib is a small molecule that inhibits multiple receptor
tyrosine kinases, some of which are implicated in tumor growth,
pathologic angiogenesis, and metastatic progression of cancer.
Sunitinib was evaluated for its inhibitory activity against a
variety of kinases (>80 kinases) and was identified as an
inhibitor of platelet-derived growth factor receptors (PDGFRα and
PDGFRβ), vascular endothelial growth factor receptors (VEGFR1,
VEGFR2 and VEGFR3), stem cell factor receptor (KIT), Fms-like
tyrosine kinase-3 (FLT3), colony stimulating factor receptor Type 1
(CSF-1R), and the glial cell-line derived neurotrophic factor
receptor (RET).
Now approved in 119 countries across diagnoses, more than
350,000 patients worldwide have been treated with SUTENT.7 SUTENT
is supported by an extensive body of evidence in scientific
literature, including more than 440 publications.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments
that have a meaningful impact on those living with cancer. As a
leader in oncology speeding cures and accessible breakthrough
medicines to patients, Pfizer Oncology is helping to redefine life
with cancer. Our strong pipeline of biologics, small molecules and
immunotherapies, one of the most robust in the industry, is studied
with precise focus on identifying and translating the best
scientific breakthroughs into clinical application for patients
across a wide range of cancers. By working collaboratively with
academic institutions, individual researchers, cooperative research
groups, governments and licensing partners, Pfizer Oncology strives
to cure or control cancer with its breakthrough medicines. Because
Pfizer Oncology knows that success in oncology is not measured
solely by the medicines you manufacture, but rather by the
meaningful partnerships you make to have a more positive impact on
people’s lives.
Pfizer Inc.: Working together for a healthier
worldTM
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, we have worked to make a difference for
all who rely on us. We routinely post information that may be
important to investors on our website at www.pfizer.com. In
addition, to learn more, please visit us on www.pfizer.com and
follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube
and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is
current as of November 16, 2017. Pfizer assumes no obligation to
update forward-looking statements contained in this release as the
result of new information or future events or developments.
This release contains forward-looking information about SUTENT
(sunitinib malate) and a new indication for SUTENT for the adjuvant
treatment of adult patients at high risk of recurrent renal cell
carcinoma following nephrectomy, including their potential
benefits, that involves substantial risks and uncertainties that
could cause actual results to differ materially from those
expressed or implied by such statements. Risks and uncertainties
include, among other things, uncertainties regarding the commercial
success of SUTENT in the new indication; the uncertainties inherent
in research and development, as well as the possibility of
unfavorable clinical trial results, including unfavorable new
clinical data and additional analyses of existing clinical data;
whether and when applications for SUTENT for the new indication may
be filed in any other jurisdictions; whether and when any such
other applications may be approved by regulatory authorities, which
will depend on the assessment by such regulatory authorities of the
benefit-risk profile suggested by the totality of the efficacy and
safety information submitted; decisions by regulatory authorities
regarding labeling and other matters that could affect the
availability or commercial potential of SUTENT; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2016 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
_________________________
1 Ferlay J, Shin HR, Bray F.GLOBOCAN 2008
v1.2, Cancer Incidence and Mortality Worldwide: IARC CancerBase No.
10 Lyon, France: International Agency for Research on Cancer; 2010.
Available at: http://globocan.iarc.fr(link is external).
Accessed September 2016.
2 Ljungberg B, Campbell S and Choi H. The
Epidemiology of Renal Cell Carcinoma. Eur Urol.
2011;60:615-621.
3 World Cancer Research Fund
International: Kidney Cancer statistics. Available from:
http://www.wcrf.org/int/cancer-facts-figures/data-specific-cancers/kidney-cancer-statistics.
Accessed March 2016.
4 What is Kidney Cancer. James Whale Fund
for Kidney Cancer. Available at:
http://www.jameswhalefund.org/kidneycancer/what-is-kidney-cancer/(link
is external). Accessed September 2016.
5 Based on comparison between 2015 Swedish
population study (76%), Navigant interviews (95%), and Quant Pulse
(79%). 2018-2022.
6 Wheler J, Johnson M, Seidman A. Adjuvant
therapy with aromatase inhibitors for postmenopausal women with
early breast cancer: evidence and ongoing controversy. Semin Oncol;
2006; 33(6): 672-80.
7 Pfizer Data on File.
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