WHIPPANY, N.J. and SOUTH SAN FRANCISCO, Calif., Aug. 27, 2013 /PRNewswire/ -- Bayer HealthCare
and Onyx Pharmaceuticals (NASDAQ: ONXX) today announced that the
U.S. Food and Drug Administration (FDA) has granted Priority Review
designation to the supplemental New Drug Application (sNDA) for the
oral multi-kinase inhibitor Nexavar® (sorafenib) tablets
under evaluation for the treatment of locally advanced or
metastatic radioactive iodine (RAI)-refractory differentiated
thyroid cancer. The FDA grants priority review status to drug
candidates that may offer a significant improvement in treatment
over existing options. The Prescription Drug User Fee Act (PDUFA)
date for completion of review by the FDA of the sNDA is
December 25, 2013.
"We are very pleased that the FDA has chosen to grant Priority
Review to sorafenib," said Pamela A.
Cyrus, M.D., Vice President and Head of U.S. Medical
Affairs, Bayer HealthCare Pharmaceuticals. "This is an important
milestone for sorafenib and the designation highlights the urgent
need for new treatments for patients with this type of thyroid
cancer who have limited or no treatment options."
"Sorafenib could offer an FDA-approved treatment option for
patients with this type of thyroid cancer," said Pablo J. Cagnoni, M.D., Executive Vice
President, Global Research & Development and Technical
Operations, Onyx Pharmaceuticals.
DECISION Trial Design
The submission is based on the DECISION (stuDy of
sorafEnib in loCally advanced or metastatIc
patientS with radioactive Iodine refractory
thyrOid caNcer) trial, 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 treatable, 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
June 30, 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.
Contacts:
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Media
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Investors
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Rose Talarico
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Amy
Figueroa
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Bayer HealthCare
Pharmaceuticals
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Onyx Pharmaceuticals,
Inc.
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(862) 404-5302
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(650)
266-2398
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Danielle Bertrand
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Onyx Pharmaceuticals, Inc.
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(650) 266-2114
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References:
1. Raghunandan Venkat and
Marlon A. Guerrero, "Recent Advances
in the Surgical Treatment of Differentiated Thyroid Cancer: A
Comprehensive Review," The Scientific World Journal,
vol. 2013. http://www.hindawi.com/journals/tswj/2013/425136/.
Accessed April 11, 2013.
2. Brown RL, de Souza JA, Cohen EEW. Thyroid Cancer:
Burden of Illness and Management of Disease. J
Cancer 2011; 2:193-199.
http://www.jcancer.org/v02p0193.htm. Accessed April 11, 2013.
3. World Health Organization: GLOBOCAN 2008. Cancer
Incidence and Mortality Worldwide in 2008.
http://globocan.iarc.fr/factsheets/populations/factsheet.asp?uno=900.
Accessed October 16, 2012.
4. Naifa Lamki Busaidy and Maria
E. Cabanillas, "Differentiated Thyroid Cancer: Management of
Patients with Radioiodine Nonresponsive Disease," Journal
of Thyroid Research, vol. 2012.
http://www.hindawi.com/journals/jtr/2012/618985/cta/. Accessed
April 11, 2013.
5. Lucia Brilli,
Furio Pacini. Future Oncology.
Targeted Therapy in Refractory Thyroid Cancer. 2011;7(5):657-668.
http://www.medscape.com/viewarticle/742987. Accessed April 22, 2013.
SOURCE Bayer HealthCare and Onyx Pharmaceuticals