Astellas’ Xtandi gains third approval in China for advanced prostate cancer

Astellas has announced a significant development in the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in China. The National Medical Products Administration (NMPA) has approved Xtandi (enzalutamide) for this condition, marking the third indication for the androgen receptor inhibitor (ARI) in the treatment of advanced prostate cancer within the country.

This new approval stems from robust data obtained from the Phase III global ARCHES and China ARCHES studies. Ahsan Arozullah, head of oncology development at Astellas, emphasized the importance of this approval, noting that it provides a vital treatment option for patients suffering from advanced prostate cancer in China.

The China ARCHES study involved 180 Chinese patients diagnosed with mHSPC, also known as metastatic castration-sensitive prostate cancer. These patients were randomly assigned to receive either Xtandi or a placebo, both in combination with androgen deprivation therapy. The results were promising, demonstrating that Xtandi significantly reduced the risk of prostate-specific antigen (PSA) progression by 87%. Additionally, patients treated with Xtandi showed improvements in radiographic progression-free survival, time to castration resistance, and PSA undetectable rates compared to those who received the placebo. Astellas highlighted that these favorable outcomes, along with the safety profile observed in the Chinese study, were consistent with the findings from the global ARCHES trial.

Xtandi's journey in China began in 2019 when the NMPA first approved it for the treatment of metastatic castration-resistant prostate cancer. This was followed by a second approval in 2020 for non-metastatic castration-resistant prostate cancer. In the United States, where Astellas co-markets Xtandi with Pfizer, the drug has obtained approvals for all three indications seen in China. Additionally, it received approval for a fourth indication in November of the previous year, specifically for non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence.

Financially, Xtandi has proven to be a significant asset for Astellas. In the fiscal year 2023, the drug generated over JPY 750 billion ($4.6 billion), marking a 14% increase compared to the previous 12-month period and surpassing initial projections of approximately JPY 720 billion ($4.5 billion).

Overall, the NMPA's recent approval of Xtandi for mHSPC in China represents a critical advancement in providing effective treatment options for patients battling advanced prostate cancer. The promising results from both the global and China ARCHES studies underscore the drug's efficacy and safety, offering hope and improved outcomes for those affected by this challenging condition.