Astellas announced that it had received approval from Japan Ministry of Health, Labour and Welfare (MHLW) for Xtandi (enzalutamide) for treating patients with metastatic hormone-sensitive prostate cancer (mHSPC) with distant metastasis. The drug is prior indicated for castration-resistant prostate cancer (CRPC).
“Today’s MHLW approval of XTANDI marks continued progress to provide a treatment option to men earlier in their advanced prostate cancer treatment journey,” said Andrew Krivoshik, Senior Vice President and Global Therapeutic Area Head, Oncology Development.
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The drug is approved based on ARCHES trial, which evaluated enzalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT. ARCHES is a Phase 3 trial, including 1,150 men with metastatic hormone-sensitive prostate cancer (mHSPC). The primary endpoint was radiographic progression-free survival (rPFS). The risk of radiographic progression or death reduced by 61% compared to placebo plus ADT.
The drug was also supported by the ENZAMET trial. The risk of death reduced by 33% compared to patients who were administered nonsteroidal anti-androgen therapy plus ADT.
The company claimed that drug safety is consistent with the safety profile of castration-resistant prostate cancer (CRPC). In the ARCHES trial, 53% of patients reported adverse events. In ENZAMET trial, only 3.0% of patients reported adverse events.
Also see other recent drug approvals in Japan
Xtandi (enzalutamide) is indicated for
Non-metastatic castration-resistant prostate cancer (nmCRPC)
Metastatic castration-sensitive prostate cancer (mCSPC)
Metastatic castration-resistant prostate cancer (mCSPC)
The drug is indicated in males and is not indicated in females or children.