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Bayer Submits Nexavar® (Sorafenib) for Marketing Authorization in Thyroid
Cancer in Japan
Regulatory submission based on positive data from Phase III DECISION trial,
in which sorafenib significantly extended progression-free survival /
Sorafenib has been granted orphan drug status for the treatment of patients
with thyroid cancer in Japan
Berlin, September 30, 2013 - Bayer HealthCare has submitted an additional
application for marketing authorization to the Ministry of Health, Labour
and Welfare (MHLW) in Japan for Nexavar® (Sorafenib) tablets, for the
treatment of locally advanced or metastatic thyroid cancer. The MHLW
granted sorafenib orphan drug status for this indication in September.
"The regulatory filing in Japan for sorafenib for the treatment of thyroid
cancer brings us another step closer to addressing a significant medical
need for patients whose disease has advanced and who have limited or no
treatment options," said Kemal Malik, M.D., Member of the Bayer HealthCare
Executive Committee and Head of Global Development. "Nexavar is already
approved for the treatment of hepatocellular carcinoma and advanced renal
cell carcinoma. We are committed to fully exploring sorafenib’s utility
across tumor types, especially in hard-to-treat cancers where there are
limited treatment options."
In June 2013, Bayer submitted Nexavar for regulatory review to the U.S.
Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
for the treatment of locally advanced or metastatic differentiated thyroid
cancer refractory to radioactive iodine (RAI). Nexavar received priority
review designation from the FDA in August of this year for this indication.
The FDA grants priority review to medicines that, if approved, would
significantly improve the efficacy or safety of treatment for serious
conditions. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims
to complete priority review within six months, rather than the standard
ten-month review cycle.
The regulatory submission is based on data from the Phase III DECISION
(stuDy of sorafEnib in loCally advanced or metastatIc patientS with
radioactive Iodine refractory thyrOid caNcer) trial, an international,
multicenter, placebo-controlled trial. In the trial, sorafenib
significantly extended progression-free survival (PFS), the primary
endpoint of the study, compared to placebo (HR=0.587 [95% CI, 0.454-0.758];
p<0.0001), which represents a 41 percent reduction in the risk of disease
progression or death for patients who received sorafenib compared to
placebo-treated patients. The median PFS was 10.8 months in patients
treated with sorafenib, compared to 5.8 months in patients receiving
The safety and tolerability profile of sorafenib in the trial were
generally consistent with the known profile of sorafenib. The most common
treatment-emergent adverse events in the sorafenib arm were hand-foot skin
reaction, diarrhea, alopecia, rash/desquamation, fatigue, weight loss and
hypertension. Results from the trial 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, Hürthle 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
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. There are more
than 213,000 new cases of thyroid cancer annually and approximately 35,000
people die from thyroid cancer worldwide each year.
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. 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.
About Nexavar® (sorafenib) Tablets
Nexavar®, an oral anti-cancer therapy for liver cancer and for the
treatment of patients with advanced kidney cancer, is currently approved in
more than 100 countries worldwide. In Europe, Nexavar is approved for the
treatment of hepatocellular carcinoma (HCC) and for the treatment of
patients with advanced renal cell carcinoma (RCC) who have failed prior
interferon-alpha or interleukin-2 based therapy or are considered
unsuitable for such therapy.
In preclinical 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 included Raf kinase, VEGFR-1, VEGFR-2, VEGFR-3, PDGFR-B, KIT, FLT-3
Nexavar is also being evaluated by Bayer and Onyx, international study
groups, government agencies and individual investigators in a range of
About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a
portfolio of innovative treatments. The oncology franchise at Bayer now
includes three oncology products and several other compounds in various
stages of clinical development. Together, these products reflect the
company’s approach to research, which prioritizes targets and pathways with
the potential to impact the way that cancer is treated.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields
of health care, agriculture and high-tech materials. Bayer HealthCare, a
subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one
of the world’s leading, innovative companies in the healthcare and medical
products industry and is based in Leverkusen, Germany. The company combines
the global activities of the Animal Health, Consumer Care, Medical Care and
Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop,
manufacture and market products that will improve human and animal health
worldwide. Bayer HealthCare has a global workforce of 54,900 employees (Dec
31, 2012) and is represented in more than 100 countries. More information
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