The Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Xtandi (enzalutamide; Astellas Pharma), that aims to expand the treatment indication to men with metastatic hormone-sensitive prostate cancer (mHSPC). 

The FDA also granted Priority Review to the application; a designation for drugs that could provide significant improvements if they are approved. 

Xtandi is an androgen receptor inhibitor currently approved to treat castration-resistant prostate cancer (CRPC). The new submission is accompanied by data from two phase 3 trials. The ‘ARCHES’ trial which enrolled 1150 men with mHSPC, who were assigned 1:1 to either receive enzalutamide 160mg/d plus androgen deprivation therapy (ADT) vs placebo plus ADT.

Results, at a median follow-up of 14.4 months, found that the enzalutamide group had a significant 61% prolongation of time to radiographic progression or death. 

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“The submission is supported by a strong data package, including two phase 3 trials investigating Xtandi in men living with this form of prostate cancer,” said Chris Boshoff, MD, PhD, CDO Oncology, Pfizer. 

Xtandi is also being evaluated in a current phase 3 trial in patients with high-risk nonmetastatic prostate cancer that has progressed after radical prostatectomy or radiotherapy, or both.

Pfizer and Astellas have an agreement to jointly commercialize enzalutamide. 

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