Evolution in the management of nmCRPC

With the relatively recent approvals of apalutamide (Erleada) and enzalutamide (Xtandi) for the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC), we are seeing intense discussion within the urologic oncology and medical oncology communities about the appropriate treatment of patients with this category of prostate cancer. … READ MORE …

When is a metastasis really metastatic today?

There is an interesting editorial commentary by Dr. Daniel George that was published just over a week ago on the UroToday web site. … READ MORE …

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 …

MFS as a new endpoint in prostate cancer drug development

An article by staff at the U.S. Food and Drug Administration (FDA) in this week’s New England Journal of Medicine (NEJM) addresses the use of metastasis-free survival (MFS) as the primary endpoint in the trial that led to approval of apalutamide (Erleada) earlier this year. … 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 …

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 …