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Approval of Enzalutamide for the Treatment of Prostate Cancer in Japan

The Japan Ministry of Health, Labour and Welfare (MHLW) approves the use of XTANDI® (enzalutamide) by Astellas Pharma Inc., for the treatment of prostate cancer with distant metastasis.

XTANDI® (enzalutamide) is an oral androgen receptor signalling 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. This is in addition to an existing indication for castration-resistant prostate cancer (CRPC).

This approval is based on results from the ARCHES trial, a randomised multi-national Phase III study evaluating enzalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in 1,150 men with mHSPC. This trial met its primary endpoint of radiographic progression-free survival (rPFS).

Data from the ENZAMET trial also supported the result which was a Phase III trial that studied enzalutamide plus ADT versus ADT plus a standard nonsteroidal antiandrogen therapy (bicalutamide, nilutamide or flutamide) in men with mHSPC.

The ARCHES trial demonstrated a reduced risk of radiographic progression or death by 61 percent for those with enzalutamide plus ADT compared to a placebo plus ADT in men with mHSPC.

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 percent 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 percent of patients. Serious adverse drug reactions observed in two or more patients were seizure (0.9%), hypertension (0.5%) and fatigue (0.4%).

“The 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.” [APBN]