Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) today announced that it
will hold a conference call to discuss data presented at an ASCO
plenary session from the DECISION study, a Phase 3 trial
investigating the use of Nexavar® (sorafenib) tablets in patients
with locally advanced or metastatic radioactive iodine-refractory
(RAI) differentiated thyroid cancer. The call will feature the
principal investigator, Marcia Brose, M.D., Ph.D., Assistant
Professor in the Abramson Cancer Center and the Perelman School of
Medicine at the University of Pennsylvania, and will include
members of Onyx's management.
Date: Monday, June 3, 2013 Time: 10:15 - 11:00 a.m. Central
Time
To access a live audio webcast of the conference call, log onto
the company's website at:
http://www.onyx.com/investors/event-calendar
To access the live conference call, dial 847-585-4405 and use
the passcode 34979134 #. A replay of the call will be available on
the Onyx website or by dialing 630-652-3042 and using the passcode
34979134 # approximately one hour after the conference call
concludes through June 17, 2013.
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 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.
Contact: Nicole Keith 650-266-2123
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