Therapy Areas: Oncology
The US Food and Drug Administration approves Janssen Pharmaceutical's Erleada
16 February 2018 -

The US Food and Drug Administration (FDA) has approved Belgium-based Janssen Pharmaceutical's androgen receptor inhibitor, Erleada (apalutamide), intended for the treatment of non-metastatic castration-resistant prostate cancer (NM-CRPC), it was reported yesterday.

The FDA approval received by the subsidiary of Johnson & Johnson comes after last week's results of the phase three SPARTAN trial in patients with NM-CRPC in which the drug was indicated to have decreased the risk of distant metastasis or death by 72%. The product was also indicated to have increased the median metastasis-free survival by more than two years in comparison with placebo.

The trial assessed the efficacy and safety of the product in comparison to placebo in over 1,200 men with NM-CRPC who had a rapidly increasing PSA while being subjected to continuous androgen deprivation therapy. The product is now the first approved treatment in the United States for NM-CRPC.

Login
Username:

Password: