Enzalutamide treatment approved for use in China

The Chinese National Medical Products Administration (NMPA) has approved a New Drug Application (NDA) for XTANDI^® (enzalutamide). The drug, produced by Astellas, is to treat adult men with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) in whom chemotherapy is not yet clinically indicated. 

The approval was based on the results from a multinational Phase III, randomised, double-blind, placebo-controlled efficacy and safety study of enzalutamide.

The drug is administered orally once daily and is an androgen receptor (AR) signalling inhibitor.

Enzalutamide directly targets ARs through:

• Inhibiting androgen binding: androgen binding induces a conformational change that triggers activation of the receptor
• Prevents nuclear translocation: translocation of the AR to the nucleus is an essential step in AR-mediated gene regulation
• Impairs DNA binding: binding of the AR to the DNA is essential for modulation of gene expression.

“Currently the treatment options are limited in China for men with metastatic castration-resistant prostate cancer,” said Dr Andrew Krivoshik, Senior Vice President and Global Therapeutic Area Head, Oncology Development, Astellas. “The approval of enzalutamide in China brings us one step closer to offering physicians a meaningful treatment option in an area where there is a high medical need.”