(Prostate Cancer) Application for Additional Use of Darolutamide
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On March 11, 2022, Bayer Yakuhin submitted an application to Japan's Ministry of Health, Labour and Welfare to expand the indication of the oral androgen receptor inhibitor (ARi) Darolutamide to include metastatic prostate cancer.
In 2020, there were over 1.4 million new prostate cancer cases globally — the second most common malignancy in men. At diagnosis, the cancer is often localized to the prostate, with options such as radical surgery and radiation therapy available. For confirmed relapsed hormone-sensitive prostate cancer with metastasis, standard treatments include androgen deprivation therapy (ADT), hormone therapy, androgen receptor inhibitors combined with ADT, and chemotherapy. Approximately 5% of patients are found to have distant metastases at initial diagnosis; these patients typically develop castration-resistant prostate cancer with limited survival within two to three years.
This application is based on results from the ARASENS Phase III clinical trial — a multicenter, double-blind trial enrolling patients with metastatic prostate cancer (N=1,306). The trial compared the efficacy and safety of Darolutamide 600 mg twice daily + ADT + chemotherapy versus placebo + ADT + chemotherapy. Results showed that Darolutamide 600 mg + ADT + chemotherapy significantly extended overall survival.
Source: https://www.pharma.bayer.jp/ja/news2022-03-11
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