FDA approves Astellas and Medivation’s expanded use of prostate cancer drug Xtandi

The approval for the use of new indication follows a priority review of the supplemental new drug application (sNDA) that was based on results of the Phase III PREVAIL trial.

Xtandi was first approved by FDA in August 2012 to treat patients who both had metastatic CRPC and had been treated with chemotherapy (docetaxel).

The new approval from FDA allows the company to use Xtandi 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 progressed despite treatment to lower testosterone.

Astellas Pharma chief medical officer and Astellas Pharma Global Development president Sef Kurstjens said, "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.

In the Phase III PREVAIL trial, men receiving Xtandi and GnRH therapy showed significant improvement in both overall survival and delayed time to radiographic progression or death as compared to those on placebo and GnRH therapy.

Image: XTANDI packaging (capsules shown not actual size). Photo: courtesy of PR Newswire.