NEXAVAR the Only Drug Therapy Proven to Significantly Improve Overall
TORONTO, Feb. 4 /CNW/ - Bayer Inc. announced today that Health Canada has
approved a new indication for NEXAVAR(R) (sorafenib tablets) for the treatment
of patients with unresectable hepatocellular carcinoma (HCC), or liver cancer.
NEXAVAR, an oral anti-cancer treatment, is the first approved drug therapy for
liver cancer, and the only one shown to significantly improve overall survival
in HCC patients who previously were without adequate treatment options.
"The approval of NEXAVAR in Canada for the treatment of HCC represents a
major advance for this patient population," said Dr. Morris Sherman, a
clinical hepatologist in Toronto and Associate Professor of Medicine. "Liver
cancer is a disease that traditionally has poor patient outcomes and until
now, there were no approved drug therapies for these patients, making their
prognosis extremely grim. NEXAVAR is a simple, non-invasive and effective
treatment for HCC, offering patients a greater chance of significantly
extending their overall survival."
Health Canada's decision to approve NEXAVAR was based on positive data
from the international Phase 3 placebo-controlled Sorafenib HCC Assessment
Randomized Protocol (SHARP) trial, which demonstrated that NEXAVAR extended
overall survival by 44 per cent in patients with HCC (HR=0.69; p=0.0006)
versus placebo. In the study, median overall survival was 10.7 months in
NEXAVAR-treated patients compared to 7.9 months in those taking placebo. No
indication of imbalances was observed in serious adverse events between the
NEXAVAR and placebo-treated groups, with the most commonly observed adverse
events in patients receiving NEXAVAR being diarrhea and hand-foot skin
"When I was told I had liver cancer and that it had progressed to a stage
where chemotherapy was no longer an option, I was devastated," said Wally
Wasylyk of Craven, Saskatchewan. "After 16 months of taking NEXAVAR in a
clinical study, my cancer is in remission and I now have a second chance at
About Liver Cancer
Hepatocellular carcinoma is the most common form of liver cancer and is
responsible for approximately 90 per cent of the primary malignant liver
tumours in adults(1)(2). It is the fifth most common cancer in the world(3)
and the third leading cause of cancer-related deaths globally(4). Incidence of
and mortality rates for liver cancer in Canada are on the rise, and for 2007,
it is estimated that there will be approximately 1,350 newly diagnosed cases
of liver cancer, an estimated half of which will be fatal(5)(6). Liver cancer
is more prevalent in men than women, with 1,040 new diagnoses in men, compared
to 310 in women(7).
"During the 30 years that HCC has been recognized as a form of cancer,
there has never been an approved drug treatment that improves survival for
patients suffering from this devastating disease," said Dr. Shurjeel Choudhri,
senior vice president, head of Medical and Scientific Affairs, Bayer
HealthCare Pharmaceuticals. "This indication for NEXAVAR in Canada, within two
years of the drug's original approval for kidney cancer, demonstrates Bayer's
commitment to expediting the clinical development of innovative therapies."
NEXAVAR targets both the tumour cell and tumour vasculature and is the
only oral multi-kinase inhibitor that does not require liver cancer patients
to interrupt their treatment schedule. In preclinical studies, NEXAVAR has
been shown to target members of two classes of kinases known to be involved in
both cell proliferation (growth) and angiogenesis (growth of new blood
vessels) - two important processes that enable cancer growth. NEXAVAR works by
slowing tumour growth and by cutting off the blood supply to the tumour
(angiogenesis). NEXAVAR acts on proteins called kinases which include RAF
kinase, VEGFR-2, VEGFR-3, PDGFR-ss, KIT, FLT-3 and RET.
NEXAVAR is also currently approved in more than 60 countries, including
Canada, the United States and in the European Union, for the treatment of
patients with advanced kidney cancer. In 2006, Therapeutic Products
Directorate of Health Canada (TPD) granted a Notice of Compliance with
Conditions (NOC/c) for NEXAVAR for treatment of patients with locally advanced
/ metastatic renal cell (clear cell) carcinoma, who have failed prior cytokine
therapy or considered unsuitable for such therapy. This authorization reflects
the promising nature of the clinical evidence which will require additional
confirmatory data. Products approved under Health Canada's NOC/c policy have
demonstrated promising benefit, are of high quality and possess an acceptable
safety profile based on a benefit/risk assessment for the approved use.
Currently, NEXAVAR is funded for primary liver cancer in British Columbia
and Quebec on a patient by patient basis. In Ontario, NEXAVAR has been denied
rapid review. It is now under review by the Joint Oncology Drug Review (JODR)
managed by Ontario. Bayer has also submitted applications to all other
provincial government authorities through the JODR Process.
Important Safety Considerations for Canadian Patients Taking NEXAVAR
Based on the currently approved product monograph for the treatment of
patients with HCC and locally advanced/metastatic kidney cancer (renal cell
carcinoma or RCC), hypertension may occur early in the course of therapy and
blood pressure should be monitored weekly during the first six weeks of
therapy and treated as needed. In the pivotal liver cancer study, incidence of
bleeding regardless of causality was reported in 18 per cent of NEXAVAR
treated patients and 20 per cent of placebo patients. Incidence of cardiac
ischemia/infarction was 2.7 per cent for NEXAVAR and 1.3 per cent for placebo.
CTCAE Grade 3 adverse events were reported in 39 per cent of patients
receiving NEXAVAR compared to 24% of patients receiving placebo. CTCAE Grade 4
adverse events were reported in 6 per cent of patients receiving NEXAVAR
compared to 8 per cent of patients receiving placebo. Overall, the most common
adverse events ((greater than or equal to)20 per cent) which were considered
to be related to NEXAVAR in patients with HCC or RCC are fatigue, weight loss,
rash/desquamation, hand-foot skin reaction, alopecia, diarrhea, anorexia,
nausea, and abdominal pain.
In the kidney cancer studies, incidence of bleeding regardless of
causality was 15 per cent for NEXAVAR versus 8 per cent for placebo and the
incidence of treatment-emergent cardiac ischemia/infarction was 2.9 per cent
for NEXAVAR versus 0.4 per cent for placebo. Most common treatment-emergent
adverse events with NEXAVAR were diarrhea, rash/desquamation, fatigue,
hand-foot skin reaction, alopecia, and nausea. Grade 3/4 adverse events were
38 per cent for NEXAVAR versus 28 per cent for placebo. Women of child-bearing
potential should be advised to avoid becoming pregnant and women with infants
should be advised against breast-feeding. In cases of any severe or persistent
side effects, temporary treatment interruption, dose modification or permanent
discontinuation should be considered.
NEXAVAR has not been studied in patients who have severe kidney problems
(in addition to kidney cancer) or severe liver problems. Of note, possible
serious side-effects with NEXAVAR include high blood pressure, bleeding, heart
attack and gastrointestinal (bowel) perforation. For Canadian NEXAVAR
prescribing information, visit www.bayerhealth.com or call 1-800-265-7382.
About Bayer Inc.
Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international
research-based group with core businesses in health care, crop science, and
innovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates
the Bayer Group's HealthCare and MaterialScience businesses in Canada. Bayer
CropScience Inc., headquartered in Calgary, Alberta operates as a separate
legal entity in Canada. Together, the companies play a vital role in improving
the quality of life for Canadians - producing products that fight diseases,
protecting crops and animals, and developing high-performance materials for
applications in numerous areas of daily life. Canadian Bayer facilities
include the Toronto headquarters and offices in Ottawa and Calgary. Bayer Inc.
has approximately 1,000 employees across Canada and had sales of over $910
million CDN in 2006. Globally, the Bayer Group had sales of over 28 billion
Euro in 2006. Bayer Inc. invested approximately $47 million CDN in research
and development in 2006. Worldwide, the Bayer Group spends the equivalent of
over 2 billion Euro in 2006 in R&D.
This news release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group 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 our annual and interim reports filed with
the Frankfurt Stock Exchange. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to future events or
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(1) World Health Organization/Hepatitis B. Web site.
Accessed January 15, 2008.
(2) Penn State Milton S. Hershey Medical Center College of
Medicine/Malignant Hepatoma. Web site.
January 15, 2008.
(3) World Health Organization. Estimates by WHO Region: Incidence. Web
Accessed January 15, 2008.
(4) World Health Organization/Cancer Fact Sheet Number 297. Web site.
Accessed January 15, 2008.
(5) Canadian Cancer Society. Canadian Cancer Encyclopedia. Available at:
Accessed January 9, 2008.
(6) Canadian Cancer Society. Canadian Cancer Encyclopedia. Available at:
Accessed January 9, 2008.
(7) Canadian Cancer Society. Canadian Cancer Encyclopedia. Available at:
Accessed January 9, 2008.
For further information:
For further information: Mark Van Tol, Laura Garcia, NATIONAL Public
Relations, (416) 586-0180, email@example.com, firstname.lastname@example.org; Alison
Bing, Bayer Inc., (416) 240-5298, email@example.com