XTANDI is now MHLW-approved for both metastatic hormone-sensitive prostate cancer and castration-resistant prostate cancer in Japan

TOKYO, May 29, 2020 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has approved XTANDI® (enzalutamide), an oral androgen receptor signaling inhibitor, for the treatment of prostate cancer patients with distant metastasis. With this approval, XTANDI is now indicated for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), a form of prostate cancer that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone.1,2 This is in addition to an existing indication for castration-resistant prostate cancer (CRPC). 

The approval for mHSPC is based on results from the ARCHES triali, a randomized multi-national Phase 3 study which evaluated enzalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in 1,150 men with mHSPC and met its primary endpoint of radiographic progression-free survival (rPFS).3 It is also supported by data from the ENZAMET trialii, an overseas Phase 3 study evaluating enzalutamide plus ADT versus ADT plus a standard nonsteroidal antiandrogen therapy (bicalutamide, nilutamide or flutamide) in men with mHSPC.4

“Enzalutamide with androgen deprivation therapy led to a significant delay in the risk of progression of metastatic disease or death, and this delay was associated with maintained quality of life and a reduced need for subsequent therapies over time.  These endpoints are all critically important to men with metastatic prostate cancer,” said Andrew Armstrong, M.D., Professor of Medicine, Surgery, Pharmacology and Cancer Biology, Director of Research in the Duke Cancer Institute’s Center for Prostate and Urologic Cancers and lead investigator of the ARCHES trial. “The research supporting the approval provides compelling evidence to consider enzalutamide as a treatment option for men with mHSPC.”

Data from the ARCHES trial showed enzalutamide plus ADT significantly reduced the risk of radiographic progression or death by 61% versus placebo plus ADT in men with mHSPC.5 The ENZAMET trial demonstrated a 33% reduction in the risk of death in men with mHSPC receiving enzalutamide plus ADT compared to those who took a nonsteroidal antiandrogen therapy plus ADT.6

The safety analyses of the ARCHES and ENZAMET trials were generally consistent with the safety profile of enzalutamide in previous clinical trials in CRPC. In the ARCHES trial, adverse drug reactions were reported in 53.0% of patients. Major adverse drug reactions with an incidence of more than 10% were hot flush (20.5%) and fatigue (14.9%). In the ENZAMET trial, serious adverse drug reactions were reported in 3.0% of patients. Serious adverse drug reactions observed in 2 or more patients were seizure (0.9%), hypertension (0.5%) and fatigue (0.4%).

“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, M.D., Ph.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development. “At Astellas, we have made a commitment to fight cancer and continue to build a robust oncology portfolio to help meet the needs of patients.”


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