According to a press release issued by Astellas and Pfizer that the FDA has granted a priority review to enzalutamide (Xtandi) for the treatment of men with metastatic hormone-sensitive prostate cancer.
Currently, Xtandi, which is an androgen receptor inhibitor, is only approved for men with castration-resistant prostate cancer. The FDA “granted a supplemental new drug application for the additional indication priority review based on results from two phase 3 trials. The trials include “the ARCHES trial, results of which were presented at this year’s Genitourinary Cancers Symposium and published in Journal of Clinical Oncology,” and the “ENZAMET trial, presented during the plenary session at this year’s ASCO Annual Meeting and published in the New England Journal of Medicine.”
Cancer ABCs has reviewed the data from these trials and believes that the FDA will be granting the request and approve Xtandi for use in men who are still castrate sensitive.
