(The following press release from Bayer was received by e-mail. It was not
confirmed by the sender.)
Dear Newsletter Subscriber,
The following news item has been released:
Not intended for U.S. and UK Media
Regorafenib from Bayer Recommended for Approval in the European Union for
the Treatment of Gastrointestinal Stromal Tumors
Final decision from European Commission expected in the third quarter of
Berlin, June 27, 2014 - The oncology compound regorafenib (Stivarga®) from
Bayer has been recommended for approval by the European Committee for
Medicinal Products for Human Use (CHMP) for the treatment of adult patients
with unresectable or metastatic gastrointestinal stromal tumors (GIST) who
progressed on or are intolerant to prior treatment with imatinib and
sunitinib. The decision of the European Commission on the approval is
expected in the third quarter of 2014. Stivarga is already approved in the
EU for the treatment of patients with metastatic colorectal cancer (mCRC).
"The recommendation by the CHMP for Stivarga brings us one step closer to
fulfilling a serious unmet medical need for patients suffering from this
rare but aggressive cancer" said Dr. Joerg Moeller, Member of the Bayer
HealthCare Executive Committee and Head of Global Development. "As an oral
multi-kinase inhibitor that targets multiple tumor pathways, Stivarga would
provide a new option for those patients with GIST who have no other
approved treatment alternatives. At Bayer, we are committed to developing
treatments that truly make a difference for patients battling the toughest
The CHMP decision is based on the results of the pivotal Phase III GRID
trial which showed that regorafenib plus best supportive care (BSC)
significantly improved progression-free survival (PFS) compared to placebo
plus BSC (HR=0.268 [95% CI 0.185-0.388], p<0.0001) in patients with
metastatic and/or unresectable GIST who were previously treated with
imatinib and sunitinib. The median PFS was 4.8 months in the regorafenib
arm versus 0.9 months in the placebo arm (p < 0.0001). The increase in PFS
was consistent independent of patient age, sex, geographic region, prior
lines of treatment or ECOG performance status.
The most frequently reported drug-related adverse events in
regorafenib-treated patients versus placebo-treated patients, respectively,
were: asthenia/fatigue, hand-foot skin reaction (HFSR) / palmar-plantar
erythrodysesthesia (PPE), diarrhea, decreased appetite and food intake,
hypertension, mucositis, dysphonia, infection, pain (not otherwise
specified), decreased weight, gastrointestinal and abdominal pain, rash,
fever and nausea. The most serious adverse drug reactions in patients
receiving Stivarga are hepatotoxicity, hemorrhage, and gastrointestinal
Results from the study were presented at the Annual Meeting of the American
Society of Clinical Oncology (ASCO) in June 2012 and published in November
2012 in the journal The Lancet.
Regorafenib is approved under the brand name Stivarga® in several countries
worldwide, including the U.S., Europe and Japan, for the treatment of
patients with mCRC. In several countries, including the U.S. and Japan, the
product has also been approved for the treatment of GIST.
About the GRID Study
GRID (GIST - Regorafenib In Progressive Disease) was a randomized,
double-blind, placebo-controlled, multi-center Phase III study of
regorafenib for the treatment of GIST. It randomized 199 patients whose
disease had progressed despite prior treatment with imatinib and sunitinib.
Patients were randomized in a 2:1 ratio to receive either regorafenib plus
BSC or placebo plus BSC to evaluate efficacy and safety. Treatment cycles
consisted of 160 mg regorafenib (or matching placebo) once daily for three
weeks on / one week off plus BSC. The primary endpoint was PFS, and
secondary endpoints included OS, time to progression, disease control rate,
tumor response rate, and duration of response. The safety and tolerability
of the two treatment groups were also compared.
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. GIST affects an
estimated 11-20 patients per million per year worldwide.
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 Stivarga® (Regorafenib)
Stivarga® (regorafenib) 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). In addition to VEGFR 1-3 it also inhibits various
oncogenic and tumor microenvironment kinases including TIE-2, RAF-1, BRAF,
BRAFV600, KIT, RET, PDGFR, and FGFR, which individually and collectively
impact upon tumor growth, formation of a stromal microenvironment and
Stivarga is a compound developed by Bayer. In 2011, Bayer entered into an
agreement with Onyx Pharmaceuticals, Inc., an Amgen subsidiary, under which
Onyx receives a royalty on all global net sales of Stivarga in oncology.
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 18.9 billion (2013), 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 56,000 employees (Dec
31, 2013) and is represented in more than 100 countries. More information
is available at http://www.healthcare.bayer.com.
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This release may contain forward-looking statements based on current
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Yours BayNews Editorial Team
51368 Leverkusen, Germany
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