Astellas Pharma Inc. (TYO: 4503), a leading Japanese pharmaceutical company, has announced that it has secured market approval in China for a new indication of its drug Xtandi (enzalutamide), marking its third such approval in the country. The drug is now approved for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), a significant development in the fight against prostate cancer.
The approval was supported by the Phase III global ARCHES and China ARCHES studies, which demonstrated that Xtandi in combination with androgen deprivation therapy (ADT) significantly reduced the risk of PSA progression by 87% compared to placebo plus ADT. Additionally, secondary endpoints showed improvement with the use of Xtandi plus ADT, with consistent results observed between the Chinese and global ARCHES studies.
Previously, Xtandi received approval in China for non-metastatic castration-resistant prostate cancer (nmCRPC) in 2020 and for metastatic castration-resistant prostate cancer (mCRPC) in patients previously treated with ADT in 2019.
In China, prostate cancer is the most prevalent cancer among the male urogenital system and is on the rise. The median survival period for Chinese patients with metastatic hormone-sensitive prostate cancer after ADT treatment is a concerning 3-4 years, highlighting the urgent need for innovative treatment options.- Flcube.com
