Astellas Pharma Inc. 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 EC approval is based on results from the Phase 3 EMBARK trial, which showed XTANDI in combination with leuprolide led to a 57.6% lower risk of disease progression or death compared to leuprolide alone. Treatment with XTANDI alone was associated with a 36.9% reduction in risk. The European Association of Urology (EAU) guidelines recommend XTANDI for men with high-risk BCR nmHSPC with or without ADT, after radiation therapy or surgery.
XTANDI is an androgen receptor signaling inhibitor indicated in the EU for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC), and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR).