March 29, 2016
Bayer Receives Approval for Xofigo® in Japan
Marketing authorization granted for the treatment of castration-resistant prostate cancer patients with bone metastasesLeverkusen, March 29, 2016 - Bayer announced today that the Ministry of Health,
Labour and Welfare (MHLW) in Japan has granted marketing authorization for
Xofigo® (radium-223 dichloride, radium-223) for the treatment of patients with
castration-resistant prostate cancer and bone metastases. The product is
already aproved in more than 40 countries worldwide, including the U.S. and the
countries of the European Union (EU).
"A majority of men living with advanced prostate cancer develop bone
metastases, resulting in symptoms that can interfere with daily life, such as
tiredness, weakness or difficulty doing normal activities, and decreased
overall survival," explained Dr. Hiroji Uemura, associate professor and
department director of Urology and Renal Transplantation, Yokohama City
University Medical Center. "Xofigo® has an anti-tumor effect that enables us to
directly target bone metastases and potentially prolong survival, a critical
treatment goal for patients with advancing disease. In addition, it is expected
to delay the time to the first symptomatic skeletal event."
Prostate cancer is the second most commonly diagnosed malignancy in men
worldwide, and its incidence is rising in Japan. 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.
"We are pleased that Xofigo is now available in Japan, providing a new and
innovative therapy with a proven clinical benefit to patients with advanced
disease," said Dr. Joerg Moeller, member of the Executive Committee of Bayer
AG's Pharmaceutical Division and Head of Development. "Prostate cancer has a
significant impact on men in Japan, and this is an important step in our
ongoing commitment to deliver therapies to patient's need."
The approval 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=0.681 (95% CI 0.542-0.857), p=0.00096]. The second
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)]. Median time to
first symptomatic skeletal event, a secondary endpoint in ALSYMPCA, was 15.6
months for radium-223 versus 9.8 months for placebo [HR= 0.658 (95% CI
The most common adverse events (occurring at a rate of 25% or greater, all
grades) in patients receiving radium-223 in the ALSYMPCA trial were bone pain
(patients treated with radium-223: 51.7%, patients in the placebo group:
63.5%), nausea (35.5%, 33.9%), anemia (31.2%, 30.6%), fatigue (26.5%, 25.9%),
diarrhea (25.7%, 15.0%). The most common hematologic laboratory abnormalities
were anemia (31.2%, 30.6%), neutropenia (5.0%, 1.0%), pancytopenia (2.0%, 0%),
thrombocytopenia (4.2%, 0.3%) and lymphocytopenia (0.8%, 0.3%).
ALSYMPCA Trial Design
The ALSYMPCA trial was a Phase III, randomized, double-blind,
placebo-controlled international study of Xofigo with best standard of care vs.
placebo with best standard of care in symptomatic castration-resistant prostate
cancer (CRPC) patients with bone metastases. Interim and updated analyses of
the trial showed Xofigo significantly improved overall survival.
About Castration-Resistant Prostate Cancer (CRPC) and Bone Metastases
The stage of prostate cancer is one of the most important factors in
determining treatment options and the outlook for recovery. If prostate cancer
spreads, or metastasizes, beyond the prostate gland, it often first grows into
nearby tissues or lymph nodes before spreading to the bones.
CRPC is an advanced form of prostate cancer. Approximately nine in 10 patients
with advanced prostate cancer (90 percent) develop bone metastases, impacting
survival and quality of life. In fact, bone metastases lead to an increased
risk of morbidity and death in patients with CRPC. Therefore, diagnosing and
treating bone metastases at the earliest onset is critical for patients.
About Xofigo® (radium-223 dichloride)
Xofigo is an alpha particle-emitting therapeutic anti-tumor pharmaceutical. The
active ingredient in Xofigo is the alpha particle-emitting isotope radium-223,
which 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.
In countries of the EU, Xofigo is indicated for the treatment of adults with
castration-resistant prostate cancer, symptomatic bone metastases and no known
visceral metastases. Radium-223 is also being studied in additional trials for
men with prostate cancer as well as in Phase II studies for women with breast
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.
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of health care and agriculture. Its products and services are designed to
benefit people and improve their quality of life. At the same time, the Group
aims to create value through innovation, growth and high earning power. Bayer
is committed to the principles of sustainable development and to its social and
ethical responsibilities as a corporate citizen. In fiscal 2015, the Group
employed around 117,000 people and had sales of EUR 46.3 billion. Capital
expenditures amounted to EUR 2.6 billion, R&D expenses to EUR 4.3 billion.
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floated on the stock market as an independent company named Covestro on October
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