China approves Astellas’ Xtandi in non-metastatic castration-resistant prostate cancer

pharmafile | November 6, 2020 | News story | Medical Communications, Sales and Marketing Astellas, China, NMPA, Xtandi 

China’s drug regulator, the National Medical Products Administration (NMPA), has given the green light to Astellas to market Xtandi (enzalutamide soft capsules) in the country as a treatment for non-metastatic castration-resistant prostate cancer (nmCRPC) with high risk of metastasis in adult patients at high risk of metastasis.

Phase 3 data supporting the authorisation showed that, when combined with androgen deprivation therapy (ADT), Xtandi demonstrated a median metastasis-free survival of 36.6 months compared to 14.7 months with placebo combined with ADT, meeting the main goal of the study. The combo also reduced the risk of radiographic progression or death by 71% over the placebo combo.

 “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,” explained said Dr Andrew Krivoshik, Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. “In clinical studies, enzalutamide significantly reduced the risk of the cancer spreading or death compared to placebo alone.”

The decision marks the second approval for Xtandi in the country after it was approved for the treatment of metastatic castration-resistant prostate cancer. It was authorised for use by the NMPA back in November last year in asymptomatic or mildly symptomatic adult men following failure of ADT, and who have not been indicated for chemotherapy.

Matt Fellows

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