FDA expands approval of Erleada to mCSPC

The US Food and Drug Administration has approved Erleada (apalutamide), from Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech, for patients with metastatic castration-sensitive prostate cancer (mCSPC).

Efficacy was demonstrated in TITAN (NCT02489318), a randomized, double-blind, placebo-controlled, multi-center clinical trial enrolling 1,052 patients with mCSPC. Patients received either apalutamide 240 mg daily or placebo, orally. All patients received androgen deprivation therapy (ADT)—either concomitant gonadotropin-releasing hormone analog or prior bilateral orchiectomy. Patients with both high- and low-volume disease were enrolled in the study.

In April this year, Erleada won European approval for non-metastatic castration-resistant prostate cancer (nmCRPC). Also, in February 2018, the US agency cleared the drug for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant).