Astellas Announces NMPA Acceptance of New Indication Application for XTANDI® (Enzalutamide) in Metastatic Hormone-Sensitive Prostate Cancer

On September 19, Astellas Pharma, Inc. announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has accepted the new indication application for XTANDI® (enzalutamide) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).

This new indication application is based on the results of the Phase III ARCHES study in China. In this study, 180 patients with mHSPC in mainland China were randomly divided into two groups: one group received Enzalutamide combined with androgen deprivation therapy, and the other group received a placebo combined with androgen deprivation therapy. The study met its primary endpoint, demonstrating a statistically significant improvement in time to prostate-specific antigen (PSA) progression (TTPP). PSA progression was defined as a ≥25% increase in PSA level from the lowest PSA value (i.e., the lowest PSA level observed at or after baseline) with an absolute value of ≥2 µg/L (2 ng/mL), confirmed by a second consecutive measurement at least three weeks later. These key findings are also consistent with the results of the global Phase III ARCHES study conducted by Astellas in the same target population.

In the China ARCHES study, the safety of Enzalutamide in combination with androgen deprivation therapy was generally consistent with the known safety profile of the drug.

Results of the ARCHES study in China to be presented as a poster at the 2023 European Society for Medical Oncology Annual Meeting.

China's National Medical Products Administration has not yet approved Enzalutamide for the treatment of metastatic hormone-sensitive prostate cancer.

Astellas has reflected the impact of this acceptance in its financial forecast for the current fiscal year (ending March 31, 2024).

About XTANDI® (Enzalutamide Soft Capsules)

Enzalutamide is an androgen receptor signaling inhibitor used to treat adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis, as well as asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC) adult patients who have failed androgen deprivation therapy (ADT) and have not received chemotherapy.

Editor: Muyan

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