January 8, 2016, Beijing – Today, Xian Janssen Pharmaceutical Ltd., announced the launch of ZYTIGA® (abiraterone acetate), a new kind of treatment for men with metastatic castration-resistant prostate cancer (mCRPC). ZYTIGA®, a once-daily oral medication for use in combination with prednisone, has the potential to extend survival and improve the quality of life for patients with mCRPC.
Treatment of mCRPC is a major challenge in China, where the average length of survival is no more than 2 years. Until now, there has been a lack of effective new therapies for mCRPC beyond traditional hormone therapy and chemotherapy.
“ZYTIGA® offers a new type of treatment option and hope for men with mCRPC. Clinical trials demonstrate that not only does ZYTIGA® extend survival, but it also improves the quality of life of patients – this is an important consideration for patients and their families,” said Prof. Li Hanzhong, Director of the Department of Surgery, Peking Union Medical College Hospital.
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 – called mCRPC.
“ZYTIGA® is a new type of treatment called an androgen biosynthesis inhibitor and is fast becoming the cornerstone of mCRPC management as recommended by local and international treatment guidelines.” said Prof. Xie Liping, Director of the Department of Urology of the First Hospital in Zhejiang Province. “ZYTIGA® works in a unique way by inhibiting grow of the tumor at three sources, including from the tumor itself.”
Known as the “silent killer,” the incidence rates of prostate cancer 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. Prostate cancer is the sixth most common cancer among men in China and is often not diagnosed until it has reached an advanced stage.
“Due to lifestyle changes, an aging population and an increase in screenings, the number of patients with prostate cancer has risen significantly, especially in big cities,” said Prof. Ye Zhangqun, Director of the Institute of Urology, Hubei Province.
“However, public awareness of prostate cancer is low, with less than 30% of the public understanding the risk factors and symptoms of prostate cancer, or the need for early screening and treatment”.
In China, men over 60 years of age are the group at highest risk of developing prostate cancer; as age increases, the risk grows. The most common symptoms of prostate cancer include blood in the urine, painful urination and bone pain.
ZYTIGA® is a once-daily oral medication for use in combination with prednisone for the treatment of men with mCPRC. With a unique mechanism of action, ZYTIGA® selectively inhibits production of androgen, which fuels prostate cancer growth, via inhibiting the CYP17 enzyme complex present at three sources: the testes, adrenals and the tumor itself.
Two Phase 3, randomized, placebo-controlled international clinical studies have proven safety and efficacy of ZYTIGA.
The COU-AA-302 Study- The study, which evaluated in 1,088 men with mCRPC who had failed androgen deprivation therapy and had not received cytotoxic chemotherapy, showed that ZYTIGA® plus prednisone/prednisolone significantly prolonged overall survival, compared to placebo plus prednisone/prednisolone, with a 19 percent risk reduction of death in patients with chemotherapy-naïve mCRPC (median OS, 34.7 vs 30.3 months, respectively; HR= 0.81 [95 percent CI, 0.70-0.93]; p = 0.0033).
- Further, the final analysis demonstrated significant improvement in time to opiate use for cancer-related pain with ZYTIGA® plus prednisone compared to placebo plus prednisone (median 33.4 vs 23.4 months, respectively; HR= 0.72 [95 percent CI, 0.61-0.85]; p = 0.0001).
- The median time to initiation of cytotoxic chemotherapy was 25.2 months for patients receiving ZYTIGA® compared to 16.8 months for patients receiving placebo (HR=0.580; 95% CI: [0.487; 0.691], p < 0.0001).
The COU-AA-301 Study
- This study evaluated 1,195 patients with mCRPC who had received prior docetaxel chemotherapy. Patients were randomized 2:1 to receive ZYTIGA® or placebo. The analysis showed that OS for those taking ZYTIGA® was 15.8 months vs. 11.2 months for the placebo group. This represents a 4.6 month difference in median survival.
The most common adverse effects seen with ZYTIGA® treatment are peripheral oedema, hypokalaemia, hypertension and urinary tract infection.
“Data from these studies demonstrate that ZYTIGA® can significantly prolong patients’ overall survival and improve quality of life,” said Avery Ince, Head of Medical Affairs and Medical Education, Xian Janssen Pharmaceutical Ltd.
“Xian Janssen is committed to caring for the well-being and health of patients and their families. We are introducing ZYTIGA® to meet the needs of patients and help reduce their suffering from mCRPC,” said Cesar Rodriguez, President of Xian Janssen Pharmaceutical Ltd. “Developing a new treatment is only one part of the battle against disease, and the other part is putting that treatment into the hands of the patients who need it most. We will continue to meet China’s growing medical and health needs through innovation and cooperation in the future.”
ZYTIGA® is now available in more than 100 cities, including Beijing, Shanghai and Guangzhou. Xian Janssen also supports the China Primary Health Care Foundation’s Patient Access Program, which provides ZYTIGA® to low-income mCRPC patients.
ZYTIGA® is approved in more than 100 countries and has been prescribed to more than 239,000 patients worldwide.