Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Diplomat has announced that the US Food and Drug Administration (FDA) has approved XTANDI to treat metastatic castration-resistant prostate cancer (CRPC).
Subscribe to our email newsletter
The new indication of XTANDI, an oral, once-daily androgen receptor inhibitor capsule, is for treatment of CRPC patients who have not received chemotherapy.
XTANDI is currently available for patients in all stages of disease progression and the approval for its new indication is based on the results of the Phase III PREVAIL clinical trial.
The Phase III trial showed that 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.
The drug was also shown to increase the amount of time before initiation of chemotherapy was deemed necessary.
Diplomat is a member of a limited panel of specialty pharmacies able to dispense XTANDI, which was first approved by the US FDA in August 2012.