April 24, 2015
Bayer Submits Marketing Authorization for Radium-223 Dichloride to Treat Prostate Cancer with Bone Metastases in Japan
Regulatory submission based on positive data from Phase III ALSYMPCABerlin, April 24, 2015 - Bayer HealthCare has submitted an application for
marketing authorization to the Ministry of Health, Labour and Welfare (MHLW) in
Japan for radium-223 dichloride (radium-223) solution for injection for the
treatment of prostate cancer patients with bone metastases.
"The number of patients suffering from prostate cancer has steadily increased
in Japan over the past years, and for patients with advanced disease, there are
limited options," said Dr. Joerg Moeller, Member of the Bayer HealthCare
Executive Committee and Head of Global Development. "With its specific mode of
action and the proven clinical benefit, radium-223 reflects our commitment to
developing innovative cancer treatments for patients for whom only limited
therapy options are available today."
The regulatory submission is based on data from the pivotal Phase III ALSYMPCA
(ALpharadin in SYMptomatic Prostate CAncer) trial as well as data from
additional trials to evaluate the safety and efficacy of radium-223 in Japanese
patients. At the interim analysis of the ALSYMPCA trial, radium-223
significantly improved overall survival (OS) [HR=0.695 (95% CI 0.552-0.875),
p=0.00185]. Median OS was 14.0 months with radium-223 plus best standard of
care vs. 11.2 months with placebo plus best standard of care. Additionally, at
the interim analysis there was a delay in the time to first symptomatic
skeletal event (SSE) for patients treated with radium-223 vs. placebo. An
updated analysis conducted after the study was unblinded showed a further
improvement in OS for patients treated with radium-223 vs. placebo, with a
median OS of 14.9 months vs. 11.3 months [HR=0.695 (95% CI 0.581-0.832)].
The most common adverse reactions (occurring at a rate of 10% or greater) in
patients receiving radium-223 in the ALSYMPCA trial were nausea, diarrhea,
vomiting and peripheral edema. The most common hematologic laboratory
abnormalities (occurring at a rate of 10% or greater) were anemia,
lymphocytopenia, leukopenia, thrombocytopenia and neutropenia.
About the ALSYMPCA Trial
The ALSYMPCA trial was a Phase III, randomized, double-blind,
placebo-controlled international study of radium-223 with best standard of care
vs. placebo with best standard of care in symptomatic castration-resistant
prostate cancer (CRPC) patients with bone metastases. The trial enrolled 921
patients in more than 100 centers in 19 countries. The study treatment
consisted of up to six intravenous injections of radium-223 or placebo each
separated by an interval of four weeks.
The primary endpoint of the study was OS. A key secondary endpoint was time to
first SSE, as defined as external beam radiation therapy (EBRT) to relieve
skeletal symptoms, new symptomatic pathologic bone fracture, occurrence of
spinal cord compression or tumor-related orthopedic surgical intervention.
About Castration-Resistant Prostate Cancer (CRPC) and Bone Metastases
Prostate cancer is the second most commonly diagnosed malignancy in men
worldwide. In 2012, an estimated 1,111,000 men were diagnosed with prostate
cancer and 307,000 died from the disease worldwide. In Japan, an estimated
47,000 men were affected with prostate cancer and 12,000 died from the disease
in 2013. Prostate cancer is the fifth leading cause of death from cancer in men
worldwide, and the sixth leading cause of death from cancer in Japanese men.
CRPC is an advanced form of prostate cancer. A majority of men with CRPC have
symptomatic bone metastases resulting in pain, skeletal events such as
fractures or spinal cord compression, and/or reduced survival. In fact, bone
metastases lead to an increased risk of morbidity and death in patients with
About Radium-223 Dichloride
Radium-223 dichloride (radium-223) is a therapeutic alpha particle-emitting
pharmaceutical with an anti-tumor effect on bone metastases. Radium-223 mimics
calcium and selectively targets bone, specifically areas of bone metastases, by
forming complexes with the bone mineral hydroxyapatite. The high linear energy
transfer of alpha emitters leads to a high frequency of double-strand DNA
breaks in adjacent tumor cells, resulting in a potent cytotoxic effect. The
alpha particle range from radium-223 is less than 100 micrometers, which
minimizes damage to the surrounding normal tissue.
Radium-223 has been approved under the brand name Xofigo® in more than 40
countries worldwide, including the U.S. and the EU.
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 around EUR 20.0 billion (2014), 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 60,700 employees (Dec 31,
2014) and is represented in more than 100 countries. More information is
available at www.healthcare.bayer.com.
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