FDA approves new indication for Xtandi in Prostate Cancer-Astellas/Medivation

The FDA approved a new indication for Xtandi (enzalutamide), from Astellas and Medivation, to treat patients with metastatic castration-resistant Prostate Cancer (CRPC). This new approved use follows a priority review of the supplemental New Drug Application that was based on results of the Phase III PREVAIL trial. The new indication approves Xtandi for use in men with metastatic CRPC who have not received chemotherapy.

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. It also 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.