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Berlin, June 28, 2012 - Bayer HealthCare announced today that the U.S. Food and
Drug Administration (FDA) has granted priority review to the New Drug
Application (NDA) filed end of April 2012 for the oral multi-kinase inhibitor
regorafenib for the treatment of patients with metastatic colorectal cancer
(mCRC) whose disease has progressed after approved standard therapies.
The FDA grants priority review to medicines that offer major advances in care
or that provide a treatment where no adequate therapy exists. Under the
Prescription Drug User Fee Act (PDUFA), the FDA will complete its review within
six months from the receipt of the NDA submission, rather than the standard
10-month review cycle.
"We welcome the priority review of regorafenib by the FDA as it supports our
efforts to make regorafenib available as early as possible to patients who have
exhausted available therapies and urgently need new options," said Dr. Kemal
Malik, Member of the Bayer HealthCare Executive Committee and Head of Global
Development.
The submission was based upon data from the pivotal, global Phase III CORRECT
study. The trial showed that oral regorafenib plus best supportive care (BSC)
significantly improved both overall survival and progression-free survival,
compared to placebo plus BSC. In this trial, the safety and tolerability of
regorafenib were generally as expected and no new or unexpected toxicity was
observed. Primary efficacy and safety data for this trial were first reported
at the Annual Gastrointestinal Cancers Symposium of the American Society of
Clinical Oncology (ASCO-GI) in January 2012 and additional data were presented
at the ASCO Annual Meeting in June 2012.
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About the CORRECT Study
The CORRECT study was an international, multicenter, randomized, double-blind,
placebo-controlled Phase III study that enrolled 760 patients with mCRC whose
disease has progressed after approved standard therapies. The study was
conducted in North America, Europe, Israel, China, Japan, and Australia.
Patients were randomized to receive either regorafenib plus BSC or placebo plus
BSC. Treatment cycles consisted of 160 mg of regorafenib (or matching placebo)
once daily for three weeks on / one week off plus BSC. The primary endpoint of
this study was overall survival. Secondary endpoints included progression-free
survival, objective tumor response rate and disease control rate. The safety
and tolerability of the two treatment groups were also compared.
In October 2011, Bayer announced that the Phase III CORRECT study met its
primary endpoint, following a pre-planned interim analysis, by significantly
improving overall survival. Based on a recommendation from an independent Data
Monitoring Committee (DMC), the study was unblinded and patients on the placebo
arm have been offered treatment with regorafenib.
About Regorafenib
Regorafenib is an investigational, oral, multi-kinase inhibitor targeting three
key mechanisms of tumor growth and progression - angiogenesis, oncogenesis, and
the tumor microenvironment. In preclinical studies, regorafenib inhibits
several angiogenic VEGF receptor tyrosine kinases that play a role in tumor
neoangiogenesis and lymphangiogenesis (the growth of new blood vessels and
lymphatic 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. Regorafenib is currently being
investigated in clinical trials for its potential to treat patients with
various tumor types.
Regorafenib is an investigational agent and is not approved by the European
Medicines Agency (EMA) or other health authorities.
In 2011, Bayer entered into an agreement with Onyx Pharmaceuticals, Inc. under
which Onyx will receive a royalty on any future global net sales of regorafenib
in oncology.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of
health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of
Bayer AG with annual sales of EUR 17.2 billion (2011), 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 55,700 employees (Dec 31, 2011) and is
represented in more than 100 countries. Find more information at
www.bayerhealthcare.com.
Find more information at www.bayerpharma.com.
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