[Beijing], [22 May 2015] – Xian Janssen Pharmaceutical Ltd. announced today
that the China Food and Drug Administration has approved ZYTIGA® (abiraterone acetate) for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).
Prostate cancer is the second most common cancer in men worldwide, accounting for almost 15% of new cancer cases, with 1.1 million cases recorded in 2012. Incidence rates in China have risen sharply in the past 10 years, especially in cities like Beijing, where the number of new patients per year jumped from 5.53 per 100,000 in 2001 to 16.62 per 100,000 in 2010, and Shanghai, where they have increased 10-fold over the past 20 years.
Known as the “silent killer”, prostate cancer is often not diagnosed until it reaches an advanced stage, showing symptoms including blood in the urine, painful urination and bone pain. Advanced-stage prostate cancer is often treated with androgen-deprivation therapy (ADT). In prostate cancer, male hormones can help fuel tumor growth and ADT reduces their levels to that achieved with castration. Though effective in treating most cases of prostate cancer, ADT can block the growth of tumors for only 18 months, after which cancer cells continue to progress. This condition is called castration-resistant prostate cancer. Sometimes the cancer will progress beyond the prostate to other parts of the body such as the bones, converting to metastatic castration-resistant prostate cancer.
“The treatment of mCRPC is a major challenge in China. There is a lack of highly-effective therapy beyond the traditional chemotherapy. The average life expectancy of castration-resistant prostate cancer (CRPC) patients is no more than 2 years4, while treatment side effects and reduced quality of life pose serious challenges for patients and their families,” said Prof. Sun Yinghao, President of Chinese Urological Association (CUA) of Chinese Medical Association (CMA) and Chairman of the Department of Urology, at the Second Military Medical University (SMMU).
“Global research shows that by reducing the level of androgen in CRPC patients, life expectancy can be extended. As a new generation of anti-androgen medication, ZYTIGA® blocks androgen production from the testes, adrenal gland and prostate tumor tissue. The approval of ZYTIGA® provides a new therapeutic option and hope for patients with mCRPC.”
“The approval of ZYTIGA® is a major milestone in treatment for patients with mCRPC in China,” said Cesar Rodriguez, President of Xian Janssen, “by introducing this breakthrough therapy into China, we are providing patients with new therapies that can prolong and improve their quality of life. In other countries, we have seen many patients benefiting from enormous gain in their quality of life. We want to bring this kind of experience to Chinese patients here. This is an important step for Xian Janssen as we introduce one of our most advanced medicines to China and continue our commitment to Chinese patients and families.”
ZYTIGA® is approved in around 100 countries, and has been used to treat more than 170,000 men worldwide.
that the China Food and Drug Administration has approved ZYTIGA® (abiraterone acetate) for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).Prostate cancer is the second most common cancer in men worldwide, accounting for almost 15% of new cancer cases, with 1.1 million cases recorded in 2012. Incidence rates in China have risen sharply in the past 10 years, especially in cities like Beijing, where the number of new patients per year jumped from 5.53 per 100,000 in 2001 to 16.62 per 100,000 in 2010, and Shanghai, where they have increased 10-fold over the past 20 years.
Known as the “silent killer”, prostate cancer is often not diagnosed until it reaches an advanced stage, showing symptoms including blood in the urine, painful urination and bone pain. Advanced-stage prostate cancer is often treated with androgen-deprivation therapy (ADT). In prostate cancer, male hormones can help fuel tumor growth and ADT reduces their levels to that achieved with castration. Though effective in treating most cases of prostate cancer, ADT can block the growth of tumors for only 18 months, after which cancer cells continue to progress. This condition is called castration-resistant prostate cancer. Sometimes the cancer will progress beyond the prostate to other parts of the body such as the bones, converting to metastatic castration-resistant prostate cancer.
“The treatment of mCRPC is a major challenge in China. There is a lack of highly-effective therapy beyond the traditional chemotherapy. The average life expectancy of castration-resistant prostate cancer (CRPC) patients is no more than 2 years4, while treatment side effects and reduced quality of life pose serious challenges for patients and their families,” said Prof. Sun Yinghao, President of Chinese Urological Association (CUA) of Chinese Medical Association (CMA) and Chairman of the Department of Urology, at the Second Military Medical University (SMMU).“Global research shows that by reducing the level of androgen in CRPC patients, life expectancy can be extended. As a new generation of anti-androgen medication, ZYTIGA® blocks androgen production from the testes, adrenal gland and prostate tumor tissue. The approval of ZYTIGA® provides a new therapeutic option and hope for patients with mCRPC.”
“The approval of ZYTIGA® is a major milestone in treatment for patients with mCRPC in China,” said Cesar Rodriguez, President of Xian Janssen, “by introducing this breakthrough therapy into China, we are providing patients with new therapies that can prolong and improve their quality of life. In other countries, we have seen many patients benefiting from enormous gain in their quality of life. We want to bring this kind of experience to Chinese patients here. This is an important step for Xian Janssen as we introduce one of our most advanced medicines to China and continue our commitment to Chinese patients and families.”
ZYTIGA® is approved in around 100 countries, and has been used to treat more than 170,000 men worldwide.