FDA Approves New Indication for Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
The U.S. Food and Drug Administration (FDA) has approved a new indication for the use of enzalutamide (Xtandi) capsules to treat patients with metastatic castration-resistant prostate cancer. The new indication is for men with metastatic castration-resistant prostate cancer who have not received chemotherapy. The approval follows a priority review of the supplemental New Drug Application (sNDA) that was based on results of the phase III PREVAIL trial.
The FDA initially approved enzalutamide, an oral, once-daily androgen receptor inhibitor, in August 2012 for patients with metastatic castration-resistant prostate cancer who previously received docetaxel.
Clinical Trial Data
In the PREVAIL trial, treatment with enzalutamide and gonadotropin-releasing hormone therapy resulted in statistically significant improvement in overall survival, reducing the risk of death by 29% (hazard ratio [HR] = 0.71, P < .0001). Enzalutamide significantly reduced the risk of radiographic progression or death by 83% (HR = 0.17, P < .0001).
When compared to placebo, treatment with enzalutamide also delayed time to initiation of chemotherapy and time to a skeletal-related event.
The safety profile for enzalutamide was updated to reflect data from both the AFFIRM and PREVAIL phase III trials. Seizure occurred in 0.9% of patients receiving enzalutamide who previously received docetaxel and 0.1% of patients who were chemotherapy-naive. The most common adverse reactions (≥ 10%) that occurred more commonly (≥ 2% over placebo) in the enzalutamide-treated patients from the two randomized clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
