Health Canada Approves Xtandi for Non-Metastatic Prostate Cancer

Astellas Pharma Canada, Inc., the Canadian subsidiary of Astellas Pharma Inc. of Tokyo, announced that Health Canada has approved a new drug application for Xtandi (enzalutamide) in the advanced treatment area of ​​prostate cancer. With this approval, Xtandi becomes the first and only androgen receptor pathway inhibitor (ARPI) approved for use alone or combined with GnRH mimetic therapy in patients with recurrent (BCR-positive) nmCSPC at high risk of metastasis.

Health Canada published a critical review of Xtandi in the nmCSPC for Project Orbis, an initiative by regulators, including Health Canada, to accelerate patient access to past cancer treatments. Prostate cancer occurs when abnormal cells form and grow in the prostate.

Prostate cancer is detected by nmCSPC when there is no evidence that the cancer has spread (metastasized) to distant parts of the body by conventional radiological methods (CT/MRI), and the tumor still responds to drugs or drugs to lower testosterone levels.

It will be considered About 20 to 40 percent of men who receive radical treatment for prostate cancer, including radical prostatectomy, radiation therapy, or both, experience biological recurrence (BCR) in the 10th year. About 9 out of 10 men with high-risk BCR will develop metastatic disease, and 1 out of 3 will die from metastatic prostate cancer.

"BCR is the first indicator of recurrence after prostate cancer treatment, and some of these patients are at high risk for early metastases and death from prostate cancer," said Fred Saad, MD, professor and chair of the Department of Medicine. University of Montreal. "We welcome the approval of Xtandi as an early treatment option for eligible patients.”This is an essential step in addressing prostate cancer needs.”