FDA approves apalutamide for treatment of mCSPC here in US

Yesterday (September 17, 2019), the US Food and Drug Administration approved apalutamide (Erleada) for treatment of men with metastatic castration-sensitive prostate cancer (mCSPC) … READ MORE …

ARCHES study data reported in JCO, and related issues

The initial data from the ARCHES study of standard ADT + enzalutamide versus standard ADT + a placebo in men with metastatic, hormone-sensitive prostate cancer were reported earlier this year at the Genitourinary Cancers Symposium in San Francisco. … READ MORE …

Full results of apalutamide in treatment of mHSPC

At the end of January, we had reported that the results of the TITAN trial — the Phase III trial of standard ADT + apalutamide (Erlead) or standard ADT + a placebo in men with metastatic, hormone-sensitive prostate cancer (mHSPC) — were positive, and that they were going to be reported at a meeting later in the year. … READ MORE …

J&J to seek approval of apalutamide in treatment of mCSPC

According to a media release issued yesterday by Johnson & Johnson, its Janssen Pharmaceuticals division has just submitted an application to the U.S. Food and Drug Administration for the approval of apalutamide (Eleada) in the treatment of men with metastatic, castration-sensitive prostate cancer (mCSPC). … READ MORE …

Positive outcomes for apalutamide in the treatment of mHSPC

According to a media release issued late yesterday by Johnson & Johnson, the combination of apalutamide (Erleada) + androgen deprivation therapy (ADT) has met the primary study endpoints in the so-called TITAN trial. … 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 apalutamide for treatment of nmCRPC

Yesterday afternoon the US Food & Drug Administration (FDA) approved apalutamide — which will have the brand name Erleada — for the treatment of men with 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 expects to file for approval to market two new prostate cancer drugs

An announcement from Johnson & Johnson yesterday said that the company is projecting filings with regulatory authorities for approval of two new drugs for the treatment of advanced prostate cancer between 2017 and 2021. … READ MORE …

Data from a Phase II trial of ARN-509 (apalutamide) and more

A report posted on line in European Urology has provided us with important clinical data related to the potential of this investigational drug in the treatment of advanced prostate cancer. … READ MORE …