PSA doubling time and prognosis for men with nmCRPC

A report this week in Urologic Oncology has confirmed the importance of PSA doubling times in understanding risk for prostate cancer progression among men with non-metastatic, castration-resistant prostate cancer (nmCRPC). … READ MORE …

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 …

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 …

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 …