Diplomat, an independent specialty pharmacy, announced that Xtandi has been granted an expanded approval by the US Food and Drug Administration (FDA) for the treatment of metastatic castration-resistant prostate cancer (CRPC). The new indication allows for the use of Xtandi in patients who have not received chemotherapy.

Xtandi is an oral, once-daily androgen receptor inhibitor capsule now available for patients in all stages of disease progression. The new indication has been approved based on the results of the phase 3 PREVAIL clinical trial. In the trial, men receiving Xtandi and treatment to lower testosterone exhibited a statistically significant improvement in both overall survival and delayed time to radiographic progression or death as compared to placebo and treatment to lower testosterone. Xtandi was also shown to increase the amount of time before initiation of chemotherapy was deemed necessary.

Metastatic CRPC is cancer that has spread beyond the prostate gland and has progressed in spite of treatment to lower testosterone.

Diplomat is a member of a limited panel of specialty pharmacies able to dispense Xtandi, which was first approved by the FDA in August 2012.