WAYNE, N.J. and SOUTH SAN FRANCISCO, Calif., July 1, 2013 /PRNewswire/ -- Bayer
HealthCare and Onyx Pharmaceuticals (NASDAQ: ONXX) today announced
the submission of a supplemental New Drug Application (sNDA) to the
U.S. Food and Drug Administration (FDA) and an application for
marketing authorization to the European Medicines Agency (EMA) for
the oral multi-kinase inhibitor Nexavar® (sorafenib)
tablets for the treatment of locally advanced or metastatic
radioactive iodine (RAI)-refractory differentiated thyroid
cancer.
"The filings in the U.S. and Europe for sorafenib for the potential
treatment of this type of thyroid cancer bring us closer to
addressing an unmet medical need for these patients who have
limited or no treatment options," said Kemal Malik, M.D., Member of the Bayer
HealthCare Executive Committee and Head of Global Development. "We
are committed to exploring sorafenib's potential applicability in
hard-to-treat cancers."
"Based on results from clinical studies we believe sorafenib
could potentially provide a new option for the treatment of
differentiated thyroid cancer that no longer responds to
radioactive iodine therapy," said Pablo J.
Cagnoni, M.D., Executive Vice President, Global Research
& Development and Technical Operations, Onyx
Pharmaceuticals.
The regulatory submission is based on data from the Phase 3
DECISION (stuDy of sorafEnib in loCally advanced or metastatIc
patientS with radioactive Iodine refractory thyrOid caNcer) trial,
an international, multicenter, placebo-controlled study. In the
trial, sorafenib significantly extended progression-free survival
(PFS), the primary endpoint of the study, compared to placebo.
Results from the study were presented at the Annual Meeting of the
American Society of Clinical Oncology (ASCO) in June 2013.
DECISION Trial Design
The DECISION (stuDy of
sorafEnib in loCally advanced or metastatIc
patientS with radioactive Iodine refractory
thyrOid caNcer) trial was an international,
multicenter, placebo-controlled study. A total of 417 patients with
locally advanced or metastatic, RAI-refractory, differentiated
thyroid cancer (papillary, follicular, Hurthle cell and poorly
differentiated) who had received no prior chemotherapy, tyrosine
kinase inhibitors, monoclonal antibodies that target VEGF or VEGF
receptor, or other targeted agents for thyroid cancer were
randomized to receive 400 mg of oral sorafenib twice daily (207
patients) or matching placebo (210 patients). Ninety-six percent of
randomized patients had metastatic disease.
The primary endpoint of the study was progression-free survival,
as defined by Response Evaluation Criteria in Solid Tumors
(RECIST). Secondary endpoints included overall survival, time to
progression, response rate and duration of response. Safety and
tolerability were also evaluated.
About Thyroid Cancer
Thyroid cancer has become the
fastest-increasing cancer in the world in recent years and is the
sixth most common cancer in women.1,2 There are more
than 213,000 new cases of thyroid cancer annually and approximately
35,000 people die from thyroid cancer worldwide each
year.3
Papillary, follicular, Hürthle cell and poorly differentiated
types of thyroid cancer are classified as "differentiated thyroid
cancer" and account for approximately 94 percent of all thyroid
cancers.4 While the majority of differentiated thyroid
cancers are curable, RAI-refractory locally advanced or metastatic
disease, is more difficult to treat and is associated with a lower
patient survival rate.4,5
About Nexavar® (sorafenib) Tablets
Nexavar is
approved in the U.S. for the treatment of patients with
unresectable hepatocellular carcinoma and for the treatment of
patients with advanced renal cell carcinoma. Nexavar is thought to
inhibit both the tumor cell and tumor vasculature. In in vitro
studies, Nexavar has been shown to inhibit multiple kinases thought
to be involved in both cell proliferation (growth) and angiogenesis
(blood supply) – two important processes that enable cancer growth.
These kinases include Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3,
PDGFR-B, KIT, FLT-3 and RET.
Nexavar is currently approved in more than 100 countries.
Nexavar is also being evaluated by Bayer and Onyx, international
study groups, government agencies and individual investigators in a
range of cancers.
Important Safety Considerations For Nexavar® (sorafenib)
Tablets
Nexavar in combination with carboplatin and
paclitaxel is contraindicated in patients with squamous cell lung
cancer.
Cardiac ischemia and/or myocardial infarction may occur.
Temporary or permanent discontinuation of Nexavar should be
considered in patients who develop cardiac ischemia and/or
myocardial infarction.
An increased risk of bleeding may occur following Nexavar
administration. If bleeding necessitates medical intervention,
consider permanent discontinuation of Nexavar.
Hypertension may occur early in the course of treatment. Monitor
blood pressure weekly during the first 6 weeks and periodically
thereafter and treat, if required.
Hand-foot skin reaction and rash are common and management may
include topical therapies for symptomatic relief. In cases of any
severe or persistent adverse reactions, temporary treatment
interruption, dose modification, or permanent discontinuation of
Nexavar should be considered. Nexavar should be discontinued if
Stevens-Johnson Syndrome or toxic epidermal necrolysis are
suspected as these may be life threatening.
Gastrointestinal perforation was an uncommon adverse reaction
and has been reported in less than 1% of patients taking Nexavar.
Discontinue Nexavar in the event of a gastrointestinal
perforation.
Patients taking concomitant warfarin should be monitored
regularly for changes in prothrombin time (PT), International
Normalized Ratio (INR) or clinical bleeding episodes.
Temporary interruption of Nexavar therapy is recommended in
patients undergoing major surgical procedures.
Nexavar in combination with gemcitabine/cisplatin is not
recommended in patients with squamous cell lung cancer. The safety
and effectiveness of Nexavar has not been established in patients
with non-small cell lung cancer.
Nexavar can prolong the QT/QTc interval and increase the risk
for ventricular arrhythmias. Avoid use in patients with congenital
long QT syndrome and monitor patients with congestive heart
failure, bradyarrhythmias, drugs known to prolong the QT interval,
and electrolyte abnormalities.
Drug-induced hepatitis with Nexavar may result in hepatic
failure and death. Liver function tests should be monitored
regularly and in cases of increased transaminases without
alternative explanation Nexavar should be discontinued.
Nexavar may cause fetal harm when administered to a pregnant
woman. Women of childbearing potential should be advised to avoid
becoming pregnant while on Nexavar and female patients should also
be advised against breastfeeding while receiving Nexavar.
Elevations in serum lipase and reductions in serum phosphate of
unknown etiology have been associated with Nexavar.
Avoid concomitant use of strong CYP3A4 inducers, when possible,
because inducers can decrease the systemic exposure of Nexavar.
Nexavar exposure decreases when coadministered with oral neomycin.
Effects of other antibiotics on Nexavar pharmacokinetics have not
been studied.
Most common adverse reactions reported for Nexavar-treated
patients vs. placebo-treated patients in unresectable HCC,
respectively, were: diarrhea (55% vs. 25%), fatigue (46% vs. 45%),
abdominal pain (31% vs. 26%), weight loss (30% vs. 10%), anorexia
(29% vs. 18%), nausea (24% vs. 20%), and hand-foot skin reaction
(21% vs. 3%). Grade 3/4 adverse reactions were 45% vs. 32%.
Most common adverse reactions reported for Nexavar-treated
patients vs. placebo-treated patients in advanced RCC,
respectively, were: diarrhea (43% vs. 13%), rash/desquamation (40%
vs. 16%), fatigue (37% vs. 28%), hand-foot skin reaction (30% vs.
7%), alopecia (27% vs. 3%), and nausea (23% vs. 19%). Grade 3/4
adverse reactions were 38% vs. 28%.
For information about Nexavar including U.S. Nexavar prescribing
information, visit
www.nexavar-us.com or call 1.866.NEXAVAR
(1.866.639.2827).
About Bayer HealthCare Pharmaceuticals Inc.
Bayer
HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals
business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer
HealthCare is one of the world's leading, innovative companies in
the healthcare and medical products industry, and combines the
activities of the Animal Health, Consumer Care, Medical Care, and
Pharmaceuticals divisions. As a specialty pharmaceutical
company, Bayer HealthCare provides products for General Medicine,
Hematology, Neurology, Oncology and Women's Healthcare. The
company's aim is to discover and manufacture products that will
improve human health worldwide by diagnosing, preventing and
treating diseases.
About Onyx Pharmaceuticals, Inc.
Based in
South San Francisco, California,
Onyx Pharmaceuticals, Inc. is a global biopharmaceutical company
engaged in the development and commercialization of innovative
therapies for improving the lives of people with cancer. The
company is focused on developing novel medicines that target key
molecular pathways. For more information about Onyx, visit the
company's website at www.onyx.com. Onyx Pharmaceuticals is on
Twitter. Sign up to follow our Twitter feed @OnyxPharm at
http://twitter.com/OnyxPharm.
Forward Looking Statements
This news release may
contain forward-looking statements based on current assumptions and
forecasts made by Bayer Group or subgroup management. Various known
and unknown risks, uncertainties and other factors could lead to
material differences between the actual future results, financial
situation, development or performance of the company and the
estimates given here. These factors include those discussed in
Bayer's public reports which are available on the Bayer Web site at
www.bayer.com. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to
future events or developments.
This news release contains "forward-looking statements" of
Onyx within the meaning of the federal securities laws. These
forward-looking statements include without limitation, statements
regarding the progress and results of the clinical development,
safety, regulatory processes, commercialization efforts or
commercial potential of Nexavar. These statements are subject to
risks and uncertainties that could cause actual results and events
to differ materially from those anticipated, including risks
related to the development and commercialization of pharmaceutical
products. Any statements contained in this press release that are
not statements of historical fact may be deemed to be
forward-looking statements. Reference should be made to Onyx's
Quarterly Report on Form 10-Q for the quarterly period ended
March 31, 2013, filed with the
Securities and Exchange Commission under the heading "Risk Factors"
for a more detailed description of such factors. Readers are
cautioned not to place undue reliance on these forward-looking
statements that speak only as of the date of this release. Onyx
undertakes no obligation to update publicly any forward-looking
statements to reflect new information, events, or circumstances
after the date of this release except as required by law.
Nexavar® is a registered trademark of Bayer
HealthCare Pharmaceuticals Inc.
References:
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Raghunandan Venkat
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SOURCE Bayer HealthCare Pharmaceuticals Inc. and Onyx
Pharmaceuticals, Inc.