Astellas/Pfizer Mulling sNDA for Xtandi

Astellas Pharma and Pfizer say they will discuss with FDA the filing of a supplemental NDA for Xtandi (enzalutamide) plus leuprolide for use in men with non-metastatic hormone-sensitive prostate cancer. The potential submission would be based on just-announced data showing the combination therapy significantly reduced the risk of metastasis or death by 58% versus placebo plus leuprolide in this patient population.

“A positive trend in the key secondary endpoint of overall survival (OS) was also observed in the Xtandi combination arm at the time of the analysis, but these data were not yet mature,” the companies say. “Patients in the trial will be followed for a subsequent final OS analysis.”

Xtandi is an androgen receptor signaling inhibitor, they say. It is currently indicated in the U.S. for treating patients with castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.