Erleada Approved for Non-Metastatic, Castration-Resistant Prostate Cancer

Approval is based on Phase 3 SPARTAN clinical trial data
Approval is based on Phase 3 SPARTAN clinical trial data

Erleada (apalutamide; Janssen) has been approved by the Food and Drug Administration (FDA) for the treatment of patients with non-metastatic, castration-resistant prostate cancer. This next-generation androgen receptor inhibitor is the first FDA-approved therapy for this indication.

The approval was supported by data from the Phase 3 SPARTAN study involving 1,207 patients with non-metastatic, castration-resistant prostate cancer. Study patients were randomized to Erleada or placebo plus androgen deprivation therapy (ADT), either with gonadotropin-releasing hormone analog therapy or surgical castration. 

Results showed Erleada decreased the risk of distant metastasis or death by 72% compared to placebo (HR = 0.28; 95% CI, 0.23-0.35; P<0.0001); the median metastasis-free survival (MFS) was 40.5 months in the Erleada group vs 16.2 months in the placebo group. This clinical benefit was consistently seen across all patient subgroups. 

The most common side effects reported with Erleada included fatigue, hypertension, rash, diarrhea, nausea, weight loss, arthralgia, falls, hot flush, decreased appetite, fractures, and peripheral edema. Severe adverse events included falls, fractures, and seizures. 

Related Articles

Erleada will be supplied as 60mg tablets in 120-count bottles.

For more information visit Erleada.com.