Restrictions
‘Xtandi’ approved by EU as a treatment for non-metastatic hormone-sensitive prostate cancer
Reporter Shin Eun-jin | Intern reporter Jeong Jun-yeop
Entered 2024/04/25 16:23
On the 23rd (local time), the European Commission approved Xtandi as a monotherapy for adult non-metastatic hormone-sensitive prostate cancer (nmHSPC) that is not suitable for salvage radiotherapy and has a high risk of biochemical recurrence (BCR). In addition, combination therapy with androgen deprivation therapy (ADT) was also approved. Xtandi is an oral androgen receptor signaling inhibitor, approved in Korea as a treatment for high-risk non-metastatic castration-resistant prostate cancer (nmCRPC) and hormone-responsive metastatic prostate cancer.
In a phase 3 clinical trial, the combination of Xtandi and leuprolide (hormone deprivation therapy) showed a 57.6% lower tumor metastasis or mortality rate than patients receiving leuprolide monotherapy. Additionally, when Xtandi was used as monotherapy, the tumor metastasis or mortality rate was 36.9% lower. “If non-metastatic hormone-sensitive prostate cancer recurs, there is a high risk of metastasis,” said Antonio Alcaraz, director of the Department of Urology at the Hospital Affiliated to the University of Barcelona, Spain, who led the clinical trial. “With this approval, doctors can now treat non-metastatic hormone-sensitive prostate cancer patients with a high risk of metastasis. “We have been able to secure a new and important treatment alternative for these patients,” he said.
Meanwhile, 20-40% of prostate cancer patients who undergo radical prostatectomy, radiation therapy, or both treatments experience biochemical recurrence within 10 years. It is known that 90% of the high-risk group for biochemical recurrence deteriorates into metastasis, increasing the risk of death.
