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 involved 1,068 men with high-risk BCR nmHSPC, a condition characterized by a doubling of prostate-specific antigen (PSA) levels within nine months or less.
The study showed that 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 2023, 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.
XTANDI was previously approved for the treatment of patients with non-metastatic castration-sensitive prostate cancer (nmCSPC; also known as nmHSPC) with BCR at high risk for metastasis in 2018.
XTANDI is an androgen receptor signaling inhibitor that has received regulatory approvals in one or more countries around the world for use in men with 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). Over one million patients have been treated with enzalutamide globally.
Important Safety Information for enzalutamide, including potential adverse events, can be found in the full Summary of Product Characteristics.
