Astellas' Enzalutamide Approved in China for New Indication in Metastatic Hormone-Sensitive Prostate Cancer

Jun 28, 2024 15:43 CST Updated 15:43

Astellas

Pharmaceutical R&D Manufacturer

▎WuXi AppTec Content Team Report

Today (June 28), the latest announcement on the official website of China's National Medical Products Administration (NMPA) shows,Astellas' Enzalutamide Soft Capsules New Indication Application Approved。According to a previous press release from Astellas, the approved indication for this drug is:For the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). According to publicly available information,This is the third indication for enzalutamide soft capsules approved in China, following previous approvals for the treatment of castration-resistant prostate cancer under different conditions.。

Screenshot source:NMPA Official Website

Prostate cancer is a common malignant tumor of the urinary system, ranking second in incidence among male malignant tumors worldwide, with the incidence increasing with age. Prostate cancer typically grows slowly and is initially confined to the prostate; however, certain types of prostate cancer are highly aggressive and can rapidly metastasize to other parts of the body beyond the prostate (such as distant lymph nodes, bones, lungs, and liver). Metastatic hormone-sensitive prostate cancer (mHSPC) is one type of metastatic prostate cancer. Studies have shown that the median survival for men with this condition after starting androgen deprivation therapy (ADT) is only 3 to 4 years, highlighting an urgent clinical need for new treatment options.

Enzalutamide is an androgen receptor (AR) signaling inhibitor that competitively inhibits the binding of androgens to their receptors, thereby suppressing the translocation of the androgen receptor into the cell nucleus and its binding to DNA.Therefore, it is not only an androgen receptor antagonist but also has an inhibitory effect on the androgen signaling pathway.Previously, the product had been approved by the NMPA for treating adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis, as well as for treating adult patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or have mild symptoms and have not received chemotherapy after failing ADT. With this latest approval in China, the drug has become an oral therapy capable of treating three different forms of advanced prostate cancer (non-metastatic and metastatic castration-resistant prostate cancer, and metastatic castration-sensitive prostate cancer).

In October 2009, Medivation (now a Pfizer company) and Astellas entered into a commercial agreement to co-develop and commercialize enzalutamide in the United States. Astellas is responsible for manufacturing worldwide, submitting all additional regulatory approval documents, and commercializing the product outside the United States.

According to an earlier press release from Astellas, the new indication approval for enzalutamide was based on the results of the Phase 3 ARCHES study conducted in China. This study was carried out across 30 research centers in mainland China, enrolling a total of 180 Chinese patients with metastatic hormone-sensitive prostate cancer (mHSPC), who were randomly assigned to receive either enzalutamide + androgen deprivation therapy (ADT) or placebo + ADT. The study met its primary endpoint:Compared with placebo + ADT, enzalutamide + ADT significantly delayed the time to progression of prostate-specific antigen (PSA, a common indicator for prostate cancer screening).. In addition, the study also met key secondary endpoints:Compared with placebo+ADT, enzalutamide+ADT significantly reduced the risk of radiographic progression-free survival and increased the proportion of patients reaching undetectable PSA levels.。

The approval and market launch of the androgen receptor signaling inhibitor Enzalutamide Soft Capsules in China is expected to bring more treatment options to some cancer patients.

References:

[1] Drug Approval Certificate Delivery Information on June 28, 2024. Retrieved June 28, 2024, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20240628152218165.html

[2] China's National Medical Products Administration Accepts the New Indication Application for XTANDI® (Enzalutamide) to Treat Metastatic Hormone-Sensitive Prostate Cancer. Retrieved Sep 19, 2023 from https://www.astellas.com.cn/zh-hans/news/14196

[3] Mottet N, et al. Updated Guidelines for Metastatic Hormone-sensitive Prostate Cancer: Abiraterone Acetate Combined with Castration Is Another Standard. Eur Urol. 2018;3:316-321.

[4] Astellas Announces Enzalutamide China ARCHES Study Meets Primary Endpoint. Retrieved Mar 14,2023 from https://www.astellas.com.cn/zh-hans/news/13876

[5] Astellas announces that Xtandi® (Enzalutamide Soft Capsules) has been approved by the National Medical Products Administration (NMPA) of China. Retrieved Nov 06,2020 from https://www.astellas.com.cn/zh-hans/news/12681

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