The Janssen Pharmaceutical Companies of Johnson & Johnson, a healthcare company, reported on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for ERLEADA for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC).

Non-metastatic castration-resistant prostate cancer (NM-CRPC) refers to a disease state when the cancer no longer responds to medical or surgical treatments that lower testosterone, but has not yet been discovered in other parts of the body using a total body bone scan or CT scan.

According to the company, AERLEADA (apalutamide), which is a next-generation androgen receptor inhibitor, is the first US FDA-approved treatment for NM- CRPC.ERLEADA administration caused decreased tumor cell proliferation and increased apoptosis, leading to decreased tumor volume in mouse xenograft models of prostate cancer.

This approval follows an US FDA Priority Review designation based upon data from the Phase 3 SPARTAN study, which demonstrated a 72% reduction in risk of distant metastasis or death, and an increase in median metastasis-free survival (MFS) by more than two years in patients with NM-CRPC.

SPARTAN, which is the company's Phase 3, randomised, double-blind, placebo-controlled, multi-centre study, enrolled 1,207 patients with non-metastatic castration-resistant prostate cancer. Patients were randomised 2:1 to receive either ERLEADA orally at a dose of 240 mg once daily, or placebo once daily, All patients received a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy.

On 8 February 2018, the company's SPARTAN study was presented at the 2018 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco and published in The New England Journal of Medicine.