Astellas’ Xtandi bags third nod in China for advanced prostate cancer
02 Jul 2024
Astellas announced Tuesday that China's National Medical Products Administration (NMPA) cleared Xtandi (enzalutamide) to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC), marking the androgen receptor inhibitor’s (ARI) third indication for advanced prostate cancer in the country.
The approval, which is backed by findings from the Phase III global ARCHES and China ARCHES studies, “expands access to a much-needed treatment option for those facing advanced prostate cancer in China," remarked Ahsan Arozullah, head of oncology development at Astellas.
The China ARCHES study randomised 180 Chinese patients with mHSPC – also referred to as metastatic castration-sensitive prostate cancer – to receive either Xtandi or placebo, both in combination with androgen deprivation therapy. Results showed that Xtandi significantly reduced the risk of prostate-specific antigen (PSA) progression by 87%, in addition to improvements on radiographic progression-free survival, time to castration resistance, and PSA undetectable rate compared with placebo. Astellas noted that the favourable findings from the Chinese study, alongside Xtandi’s safety profile, were in line with the global ARCHES trial.
Xtandi was first approved by the NMPA in 2019 to treat metastatic castration-resistant prostate cancer, followed by a second nod in 2020 for non-metastatic castration-resistant prostate cancer. In the US, where it is co-marketed with Pfizer, the ARI holds approvals for all three indications plus a fourth indication of non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence, secured in November last year.
Xtandi generated over JPY 750 billion ($4.6 billion) in fiscal year 2023, a 14% increase over the previous 12-month period and exceeding projections of around JPY 720 billion ($4.5 billion).
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