Astellas Korea said Wednesday that its prostate cancer treatment, Xtandi, (ingredient name: enzalutamide), will be covered by selective benefits in treating hormone-responsive metastatic prostate cancer (mHSPC) combined with androgen deprivation therapy (ADT).
Xtandi is a prostate cancer treatment with the most indications among androgen receptor-targeted agents (ARTA) in Korea. It won domestic approval in June 2013 as metastatic castration-resistance prostate cancer (mCRPC) treatment and received approval to treat metastatic prostate cancer in 2021.
This screening benefit of Xtandi is applied to all mHSPC patients (All Comer) progressive prostate cancer patients with remote metastasis, regardless of the volume or risk of the disease, Astellas Korea said.
When mHSPC progresses to the metastatic castration-resistant prostate cancer (mCRPC) stage and does not respond to hormone treatment, the life expectancy is only nine to 13 months, requiring early and effective treatment strategies.
The insurance benefit was based on international guidelines and phase 3 ARCHES clinical studies, in which the Xtandi combination therapy significantly reduced the risk of disease progression and death for patients with mHSPC. In addition, significant improvement was confirmed in the combination administration group of Xtandi and ADT, compared to the placebo and ADT combination administration group, where the median progression-free survival median (median rPFS) was only 19 months.
"Although prostate cancer has made significant progress through the introduction of various drugs and active therapies, hormone-responsive metastatic prostate cancer still has limited treatment options," said Kim Sun-il, vice chairman of the Korean Urological Oncology Society.
Kim Jin-hee, head of the Anti-Cancer Division of Astellas Korea, said, “The health insurance benefits coverage is an achievement that came about 11 months after Xtandi obtained indications for the treatment of mHSPC.”
Kim added that the company expects to contribute to the early treatment outcomes of patients with metastatic prostate cancer in Korea.
Xtandi-ADT combination therapy is recommended for hormone-responsive metastatic prostate cancer treatment in foreign guidelines, such as the National Comprehensive Cancer Network (NCCN), the American Urological Association (AUA), the European Society for Medical Oncology ESMO), and the European Association of Urology (EAU).