Pfizer Inc. (NYSE:PFE) today announced that the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has recommended against expanding use of SUTENT®
(sunitinib) to include the adjuvant treatment of adult patients at
a high risk of recurrent renal cell carcinoma (RCC) following
nephrectomy (surgical removal of the cancerous kidney). The CHMP’s
recommendation is not binding but will now be taken into
consideration by the European Commission (EC). There is currently
no approved adjuvant treatment option available for patients with
non-metastatic RCC at high risk for recurrence in the European
Union (EU).
In the U.S., SUTENT is approved for the adjuvant treatment of
adult patients at high risk of recurrent RCC following
nephrectomy.
“We remain confident in the potential of SUTENT for RCC patients
at high risk of their cancer returning after surgery who today are
restricted to a wait and see, or more accurately, a wait and worry
approach,” said Mace Rothenberg, MD, chief development officer,
Oncology, Pfizer Global Product Development. “We will continue to
work closely with the European Medicines Agency as they complete
their review and render a decision on this application.”
On November 16, 2017, the U.S. Food and Drug Administration
approved an expanded indication for SUTENT as the first treatment
for adult patients at high risk of recurrence following
nephrectomy. The FDA expanded indication was based on results from
the S-TRAC trial, 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
recurrence following nephrectomy. The results were published by The
New England Journal of Medicine in October 2016.
Each year, approximately 338,000 new cases of kidney cancer are
diagnosed worldwide, representing approximately 2-3 percent of all
cancers.1,2,3 Approximately 75 percent of patients with clear cell
RCC are non-metastatic, and 70-80 percent will have a nephrectomy
with curative intent.4 Patients at high risk of recurrence
represent approximately 10 percent of all patients with primary
resected RCC and approximately 60 percent of these patients will
recur and develop metastatic disease within five years.5
Pfizer is dedicated to addressing the unmet needs of patients
and has been advancing the science of RCC for the last decade
through research into established and novel compounds. Our
near-term areas of focus include expanding access of our marketed
products, exploration of biomarkers to better personalize therapy
and immunotherapy combinations.
SUTENT Important Safety Information
Boxed Warning/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%), hypertension (8% vs 1%), and mucositis/stomatitis (6%
vs 0%).
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%).
Most common ARs & most common grade 3/4 ARs
(imatinib-resistant or -intolerant GIST): The most common ARs
reported in ≥20% of patients with GIST and more commonly with
SUTENT than placebo (all grades, vs placebo) were diarrhea (40% vs
27%), anorexia (33% vs 29%), skin discoloration (30% vs 23%),
mucositis/stomatitis (29% vs 18%), asthenia (22% vs 11%), altered
taste (21% vs 12%), and constipation (20% vs 14%). The most common
grade 3/4 ARs reported in ≥4% of patients with GIST receiving
SUTENT (vs placebo) were asthenia (5% vs 3%), hand-foot syndrome
(4% vs 3%), diarrhea (4% vs 0%), and hypertension (4% vs 0%).
Most common grade 3/4 lab abnormalities (imatinib-resistant
or -intolerant GIST): The most common grade 3/4 lab
abnormalities (occurring in ≥5% of patients with GIST receiving
SUTENT vs placebo) included lipase (10% vs 7%), neutrophils (10% vs
0%), amylase (5% vs 3%), and platelets (5% vs 0%).
Most common ARs & most common grade 3/4 ARs (advanced
pNET): The most common ARs reported in ≥20% of patients with
advanced pNET and more commonly with SUTENT than placebo (all
grades, vs placebo) were diarrhea (59% vs 39%), stomatitis/oral
syndromes (48% vs 18%), nausea (45% vs 29%), abdominal pain (39% vs
34%), vomiting (34% vs 31%), asthenia (34% vs 27%), fatigue (33% vs
27%), hair color changes (29% vs 1%), hypertension (27% vs 5%),
hand-foot syndrome (23% vs 2%), bleeding events (22% vs 10%),
epistaxis (21% vs 5%), and dysgeusia (21% vs 5%). The most common
grade 3/4 ARs reported in ≥5% of patients with advanced pNET
receiving SUTENT (vs placebo) were hypertension (10% vs 1%),
hand-foot syndrome (6% vs 0%), stomatitis/oral syndromes (6% vs
0%), abdominal pain (5% vs 10%), fatigue (5% vs 9%), asthenia (5%
vs 4%), and diarrhea (5% vs 2%).
The most common grade 3/4 lab abnormalities (advanced
pNET) included decreased neutrophils (16% vs 0%), increased
glucose (12% vs 18%), increased alkaline phosphatase (10% vs 11%),
decreased phosphorus (7% vs 5%), decreased lymphocytes (7% vs 4%),
increased creatinine (5% vs 5%), increased lipase (5% vs 4%),
increased AST (5% vs 3%), and decreased platelets (5% vs 0%).
Please see full Prescribing Information, including BOXED
WARNING and Medication Guide, for SUTENT® (sunitinib malate) at
www.SUTENT.com.
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).
SUTENT is indicated in the U.S. for the treatment of
gastrointestinal stromal tumor (GIST) after disease progression on
or intolerance to imatinib mesylate; the treatment of advanced
renal cell carcinoma (RCC); the adjuvant treatment of adult
patients at high risk of recurrent RCC following nephrectomy; the
treatment of progressive, well-differentiated pancreatic
neuroendocrine tumors (pNET) in patients with unresectable locally
advanced or metastatic disease.
About Pfizer Oncology
Pfizer Oncology is committed to pursuing innovative treatments
that have a meaningful impact on people living with cancer. Our
growing pipeline of biologics, small molecules, and immunotherapies
is focused on identifying and translating the best scientific
breakthroughs into clinical application for patients across a
diverse array of solid tumors and hematologic cancers. Today, we
have 10 approved oncology medicines and 17 assets currently in
clinical development. By maximizing our internal scientific
resources and collaborating with other companies, government and
academic institutions, as well as non-profit and professional
organizations, we are bringing together the brightest and most
enterprising minds to take on the toughest cancers. Together we can
accelerate breakthrough treatments to patients around the world and
work to redefine life with cancer.
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 February 23, 2018. 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), Pfizer’s oncology portfolio and a potential 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
potential new indication; the uncertainties inherent in research
and development, including 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 potential new indication may be
filed in any other jurisdictions; whether and when the European
Commission will approve the Marketing Authorization Application for
SUTENT for the potential new indication and 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, 2017 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 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 February 2018.
2 Ljungberg B, Campbell S and Choi H. The Epidemiology of Renal
Cell Carcinoma. Eur Urol. 2011;60:615-621.
3 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
February 2018.
4 Based on comparison between 2015 Swedish population study
(76%), Navigant interviews (95%), and Quant Pulse (79%).
2018-2022.
5 Pfizer. Data on file. 2018.
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