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Bayer’s Regorafenib Submitted for European Marketing Authorization for the
Treatment of Gastrointestinal Stromal Tumors (GIST)
EMA filing follows EU approval of Stivarga® (regorafenib) for use in
metastatic colorectal cancer 
Berlin, September 5, 2013 - Bayer HealthCare has submitted an application
for marketing authorization to the European Medicines Agency (EMA) for the
oral multi-kinase inhibitor, regorafenib, for the treatment of patients
with gastrointestinal stromal tumors (GlST) who have been previously
treated with two tyrosine kinase inhibitors. The EMA filing follows the EU
approval of regorafenib (Stivarga®) for use in metastatic colorectal cancer
in August 2013. 
"The submission of regorafenib to EMA is an exciting advance because it
means patients with GIST will have a potential new treatment option to help
manage an aggressive disease", said Kemal Malik, M.D., Member of the Bayer
HealthCare Executive Committee and Head of Global Development. "We look
forward to offering patients and physicians a new path forward." 
"GIST is a disease that only affects a limited number of people, about 15
per million per year. However, of those who are affected over half develop
recurrent metastatic disease, for which there are currently very few
treatment options once resistance to first line treatments are observed",
said Prof. Jean-Yves Blay, M.D., Ph.D, University Claude Bernard Lyon,
Centre Léon Bérard, Department of Medicine, French Sarcoma Group
(GSF-GETO), European Organisation for Research and Treatment of Cancer
(EORTC). "The results from the GRID study suggest a significant progression
free survival benefit for patients with GIST who have been treated with
Stivarga is approved in the USA, Europe and Japan, for the treatment of
patients with metastatic colorectal cancer (mCRC). Stivarga has also been
approved in the USA and Japan for the treatment of GIST. 
About Gastrointestinal Stromal Tumors (GIST)
GIST is the most common form of sarcoma arising from the muscle wall of the
gastrointestinal tract. GIST represents a life-threatening malignancy if
the disease has spread to other parts of the body (metastasized) or is
unable to be surgically removed with curative intent. The incidence of GIST
is estimated to be 1.5 cases per 100,000 people in Europe. At the point of
diagnosis, an estimated 10-25 percent of GIST cases have disease that has
The discovery of oncogenic KIT kinase mutations in GISTs and the
introduction of kinase inhibitor therapies have led to a rapid evolution in
the understanding of these tumors. It is now established that 70-80% of
GISTs harbor a KIT gene mutation, that these mutations lead to the
continued activation of the kinase and that mutant KIT is a clinically
important therapeutic target in GIST. 
About regorafenib (Stivarga®)
Stivarga® is an oral multi-kinase inhibitor that inhibits various kinases
within the mechanisms involved in tumor growth and progression -
angiogenesis, oncogenesis and the tumor microenvironment. In preclinical
studies, Stivarga inhibits several angiogenic VEGF receptor tyrosine
kinases that play a role in tumor neoangiogenesis (the growth of new blood
vessels). It also inhibits various oncogenic and tumor microenvironment
kinases including, KIT, RET, PDGFR, and FGFR, which individually and
collectively impact upon tumor growth, formation of a stromal
microenvironment and disease progression. 
Stivarga is a compound developed by Bayer and jointly promoted by Bayer and
Onyx in the USA. In 2011, Bayer entered into an agreement with Onyx, under
which Onyx receives a royalty on all global net sales of Stivarga in
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 that have regulatory approval or are
undergoing regulatory review and several other compounds in earlier 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 55,300 employees (Dec
31, 2012) and is represented in more than 100 countries. More information
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Forward-Looking Statements
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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
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which are available on the Bayer website at The
company assumes no liability whatsoever to update these forward-looking
statements or to conform them to future events or developments. 
Doreen Schröder, Tel. +49 30 468-11399
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