Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, „Astellas“) today announced the European Commission (EC) has approved a label extension for XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy.
The extended approval for XTANDI is based on results from the Phase 3 EMBARK trial in 1,068 men with high-risk BCR nmHSPC, in whom levels of prostate-specific antigen (PSA), the biomarker which can be indicative of prostate cancer activity, doubled in nine months or less. The study showed patients treated with XTANDI in combination with leuprolide had a 57.6% lower chance of their cancer spreading or dying compared to those treated with leuprolide alone. Participants who were treated with XTANDI alone had a 36.9% reduction in risk.
The European Association of Urology (EAU) revised their treatment guidelines in April 2024, recommending enzalutamide for men with high-risk BCR nmHSPC with or without ADT, after radiation therapy or surgery. Up until now, there has been no consensus on the standard of care for men in this setting.
Don’t miss: https://newsroom.astellas.us/2023-11-16-Pfizer-and-Astellas-XTANDI-R-Approved-by-U-S-FDA-in-Earlier-Prostate-Cancer-Treatment-Setting
