BRIEF—Approval for Xtandi in China

6 November 2020

Japan’s Astellas Pharma has won approval in China for Xtandi (enzalutamide) for people with non-metastatic castration-resistant prostate cancer (nmCRPC), adding to an existing approval in metastatic CRPC.

The decision is based on results from the Phase III PROSPER trial, results from which were published in the New England Journal of Medicine in 2020.

Global oncology head Andrew Krivoshik said: “In order to maintain quality of life for men with non-metastatic prostate cancer, new treatments are needed to delay the progression of prostate cancer and prevent it from spreading to other areas in the body.”

He added: “In clinical studies, enzalutamide significantly reduced the risk of the cancer spreading or death compared to placebo alone.”