An oral androgen receptor inhibitor whose clinical testing in metastatic hormone-sensitive prostate cancer (mHSPC) was co-led by Christopher Sweeney, MBBS of Dana-Farber Cancer Institute, has become a standard first-line therapy for men starting hormonal therapy for metastatic prostate cancer.
The drug, enzalutamide (XTANDI), was approved today by the U.S. Food and Drug Administration (FDA) for men with mHSPC – also referred to as metastatic, castration-sensitive prostate cancer (mCSPC). Enzalutamide is a current standard of care in castration-resistant prostate cancer and this approval helps make the drug available to men earlier in their cancer journey.
The benefits of enzalutamide were borne out in the ANZUP-led international randomized, phase III ENZAMET trial, published in the New England Journal of Medicine. Sweeney, study co-chair, presented interim analysis earlier this year during the plenary session at the American Society of Clinical Oncology (ASCO) Annual Meeting. The ENZAMET trial is not listed on the FDA-label but did provide valuable clinical information in the mHSPC setting.
