FDA expands approval for Xtandi caps

SAN FRANCISCO, Calif. and TOKYO, Japan — Medivation and Astellas Pharma on Wednesday announced that the Food and Drug Administration approved a new use of Xtandi (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer. The new approval follows a priority review of the supplemental new drug application that was based on results of a phase-three Prevail trial. 

 

The FDA's first approval for Xtandi in August 2012 was for patients with metastatic CRPC who had previously received chemotherapy. The new indication approves the drug for use in men with metastatic CRPC who haven't received chemotherapy. Metastatic CRPC is cancer that has spread beyond the prostate gland and has progressed despite treatment to lower testosterone, the companies stated. 

 

The FDA’s priority review and approval of this new indication for XTANDI now enables the use of an important therapy by patients with metastatic castration-resistant prostate cancer at all stages of their disease,” said Sef Kurstjens, M.D., Ph.D., chief medical officer of Astellas Pharma and president of Astellas Pharma Global Development. “We are pleased that these patients now have XTANDI available as a treatment option.”