FDA approves use of enzalutamide (Xtandi) for nmCRPC

As we predicted just a couple of weeks ago, on Friday the US Food and Drug Administration (FDA) approved the use of enzalutamide (Xtandi) for the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC), … READ MORE …

Evolutions in the treatment of nmCRPC — redux

So at the Genitourinary Cancers Symposium in San Francisco today we were presented with full reports on the SPARTAN trial and the PROSPER trial by Drs. Eric Small and Maha Hussain, respectively. … READ MORE …

Evolutions in the treatment of nmCRPC

So we now have news reports and abstracts telling us what the top-line results of the SPARTAN trial and the PROSPER trial are in the treatment of men with non-metastatic, castration-resistant prostate cancer (nmCRPC). … READ MORE …

FDA gives priority review status to NDA for apalutamide

Apparently the US Food and Drug Administration (FDA) will give a priority review to apalutamide (formerly known as ARN-509), based on data from the Phase III SPARTAN  trial in men with non-metastatic castration-resistant prostate cancer (nmCRPC). … READ MORE …

J&J announces positive data from the SPARTAN trial of apalutamide (ARN-509)

We understand that Janssen Biotech has, earlier today, submitted a New Drug Application to the US Food & Drug Administration for the approval of apalutamide (formerly ARN-509) in the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC). … READ MORE …

Phase III PROSPER trial of enzalutamide + ADT successful in nmCRPC

The Phase III PROSPER trial of enzalutamide + androgen deprivation therapy (ADT) versus a placebo + ADT in men with non-metastatic castration-resistant prostate cancer (nmCRPC) has apparently met its primary endpoint of improved metastasis-free survival. … READ MORE …

An update on ODM-201 in the treatment of advanced prostate cancer

A while back now (in late 2014) Bayer initiated Phase III trials of the investigational agent ODM-201 — now also known as daralutamide — in the treatment of advanced prostate cancer. … READ MORE …