FDA Approves Apalutamide for Non-Metastatic Castration-Resistant Prostate Cancer

Approval is based on findings from the SPARTAN study

On 14 February 2018, the US Food and Drug Administration (FDA) approved apalutamide (Erleada™, Janssen Biotech, Inc.) for patients with non-metastatic castration-resistant prostate cancer (CRPC). 

Approval was based on a multicentre, double-blind, clinical trial (SPARTAN, NCT01946204) randomising 1,207 patients with non-metastatic CRPC (2:1) to receive either apalutamide, 240 mg orally once daily in combination with androgen deprivation therapy (ADT) comprised of either medical castration or surgical castration (n=806), or placebo once daily with ADT (n=401). 

The major efficacy endpoint was metastasis-free survival (MFS) that was defined as the time from randomisation to the time of first evidence of distant metastasis (new bone or soft tissue lesions or enlarged lymph nodes outside the pelvis), or death due to any cause, whichever occurred first. The estimated median MFS was 40.5 months for patients receiving apalutamide and 16.2 months for those receiving placebo (hazard ratio 0.28; 95% CI: 0.23, 0.35; p<0.0001). 

The results from SPARTAN trial were presented in part at the Genitourinary Cancers Symposium (8-10 February 2018, San Francisco, US) and simultaneously published in The New England Journal of Medicine on 8 February.  

The most common adverse reactions in at least 10% of patients were fatigue, hypertension, rash, diarrhoea, nausea, weight decreased, arthralgia, fall, hot flush, decreased appetite, fracture, and peripheral oedema. 

The recommended apalutamide dose is 240 mg (four 60 mg tablets) administered orally once daily. 

Full prescribing information is available here

FDA granted this application priority review. 

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.