Markham-based Astellas Pharma Canada's XTANDI® (enzalutamide) Receives Health Canada Approval as the First and Only Treatment for High-Risk Patients with Non-Metastatic Castration-Sensitive Prostate Cancer (nmCSPC)

Feb 05, 2024

On January 30, 2024, Astellas Pharma Canada, Inc. announced that Health Canada has approved a supplemental New Drug Application for XTANDI® (enzalutamide) in a new prostate cancer treatment setting. With this approval, XTANDI becomes the first and only androgen receptor pathway inhibitor (ARPI) approved for use with or without a GnRH analog therapy in patients with nmCSPC with biochemical recurrence at high risk for metastasis (high-risk BCR).

Health Canada granted a priority review of XTANDI in nmCSPC, which was further expedited as a result of XTANDI’s inclusion in Project Orbis, an initiative of regulatory bodies, including Health Canada, with an aim to give patients faster access to promising cancer treatments around the world.

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