Areas of consensus at APCCC last year … see Table 1

So your sitemaster has been looking through the full report from the APCCC meeting held in Basel last year — as he promised he would. … READ MORE …

ADT + darolutamide extends overall survival in men with nmCRPC

According to a media release issued by Bayer a couple of days ago, the combination of androgen deprivation therapy (ADT) + darolutamide (Nubeqa) extends overall survival “significantly” in men with non-metastatic, castration-resistant prostate cancer (nmCRPC). … READ MORE …

FDA approves darolutamide for treatment of nmCRPC

Bayer’s US pharmaceutical division has announced that the US Food and Drug Administration (FDA) has approved darolutamide — their formerly investigational androgen receptor inhibitor — for the treatment of men with non-metastatic, castration-resistant prostate cancer (nmCRPC). … READ MORE …

Darolutamide (ODM-201) in the treatment of nmCRPC

Earlier this year we had reported on the initial presentation of data demonstrating the efficacy and safety of darolutamide (formerly known as ODM-201), a third “super-antiandrogen” — similar to enzalutamide (Xtandi) and apalutamide (Erleada), in the treatment of non-metastatic, castration-resistant prostate cancer (nmCRPC). … READ MORE …

Darolutamide (ODM-201) in the treatment of nmCRPC

Also on Thursday in San Francisco, Dr. Karim Fizazi presented the initial results from the ARAMIS trial of darolutamide (formerly known as ODM-201) in the treatment of men with non-metastatic, castration-resistant prostate cancer (nmCRPC). … READ MORE …

Apalutamide (Erleada) approved in EU for treatment of nmCRPC

Yesterday, Janssen Pharmaceuticals announced the approval of apalutamide (Erleada) by the European Commission (EC) for the treatment of men with non-metastatic, castration-resistant prostate cancer (nmCRPC) who are at high risk for development of metastatic disease. … READ MORE …

ODM-201 meets Phase III goal in treatment of nmCRPC

Like other, similar drugs before it, ODM-201 — now properly known by the generic name darolutamide — has apparently hit the primary goal of metastasis-free survival in the Phase III ARAMIS trial, as announced yesterday by Bayer and Orion. … READ MORE …

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 …

Contemporary questions about the initial treatment of advanced forms of prostate cancer

So the discussion about how to use the data from the CHAARTED, STAMPEDE, and LATITUDE trials in the initial treatment of men with node-positive and metastatic hormone-sensitive and castration-resistant prostate cancer continues to be an issue of intense discussion among urologic and medical oncologists. … READ MORE …