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FDA approved XTANDI for the treatment of metastatic castration-resistant prostate cancer.
Medivation, San Francisco, CA, and Astellas Pharma, Tokyo, Japan, announced on Sept. 10, 2014 that FDA approved a new indication for the use of XTANDI(enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC). FDA initially approved XTANDI, an oral, once-daily androgen receptor inhibitor, in August 2012 for use in patients with metastatic CRPC who previously received docetaxel (chemotherapy). The new indication approves XTANDI for use in men with metastatic CRPC who have not received chemotherapy. Metastatic CRPC is defined as a cancer that has spread beyond the prostate gland and has progressed despite treatment to lower testosterone (i.e., with a gonadotropin-releasing hormone [GnRH] therapy or with removal of the testes).
According to Medivation, in the Phase III PREVAIL trial, men receiving XTANDI and GnRH therapy exhibited a statistically significant improvement in both overall survival and delayed time to radiographic progression or death as compared to those on placebo and GnRH therapy. XTANDI significantly reduced the risk of radiographic progression or death by 83% compared with placebo. XTANDI significantly reduced the risk of death by 29% compared with placebo. When compared to placebo, treatment with XTANDI also delayed time to initiation of chemotherapy and time to a skeletal related event.
A variation application to amend the European Marketing Authorization Application based on the results of PREVAIL was validated for review by the European Medicines Agency on April 24, 2014.