Plus   Neg

Astellas: XTANDI Approved In China To Treat Non-Metastatic Castration-Resistant Prostate Cancer

Japan-based Astellas Pharma Inc. (ALPMY) announced Friday that the China National Medical Products Administration or NMPA has approved XTANDI (enzalutamide soft capsules) to treat non-metastatic castration-resistant prostate cancer.

The approval is based on results from the PROSPER trial, a double-blind, placebo-controlled, pivotal Phase 3 trial that evaluated enzalutamide plus ADT versus placebo plus ADT in 1,401 men with nmCRPC and rapidly rising prostate-specific antigen levels.

The trial results demonstrated a 71 percent reduction in the risk of radiographic progression or death in men who received enzalutamide plus ADT, compared to placebo plus ADT.

Results from the study's overall survival secondary endpoint were published in the New England Journal of Medicine in 2020.

NMPA has already approved Enzalutamide in China for adult men with metastatic castration-resistant prostate cancer or mCRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy or ADT, in whom chemotherapy is not yet indicated.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT