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.
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.
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.