Median OS of men with CRPC may have doubled since 2003

A new article in European Urology suggests that the mean life expectancy for men participating in recent clinical trials and expanded access programs for new drugs for the treatment of chemotherapy-naive, castration-resistant prostate cancer (CRPC) — including metastatic and non-metastatic patients — is now just over 30 months. … READ MORE …

Zytiga approved in Europe for chemotherapy-naive mCRPC

As in the USA and some other countries, the European Union has now approved abiraterone acetate (Zytiga®), in combination with prednisone or prednisolone, for the treatment of men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Abiraterone acetate in chemotherapy-naive mCRPC: full data published

An article published this week in the New England Journal of Medicine gives the full results of the Phase III trial of abiraterone acetate + prednisone in men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC). These data were originally reported at the ASCO annual meeting in 2011. … READ MORE …

Data from MAINSAIL trial provides us with a cautionary tale

In November 2011 we reported that Celgene had terminated the Phase III, MAINSAIL trial of lenalidomide (Revlimid®) in combination with docetaxel and prednisone in treatment of men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC) for lack of efficacy. … READ MORE …

Overall survival among chemo-naive, mCRPC patients in the abiraterone acetate Phase III trial

There appears to be a great deal of confusion about the overall survival (OS) data related to the recent approval of abiraterone acetate for chemotherapy-naive patients with metastatic, castration-resistant prostate cancer (mCRPC). Let’s try to really clarify this. … READ MORE …

Data from trial of abiraterone in chemo-naive mCRPC published in NEJM

This week’s issue of the New England Journal of Medicine (NEJM) carries the full report of the results of the so-called COU-AA-302 trial of abiraterone + prednisone vs. a placebo + prednisone in men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

FDA approves abiraterone acetate for chemotherapy-naive mCRPC

According to an announcement earlier today, the U. S. Food and Drug Administration (FDA) has approved an expanded indication for abiraterone acetate (Zytiga®) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC), inclusive of patients who have not received any form of chemotherapy. … READ MORE …

Abiraterone acetate in chemotherapy-naive mCRPC — Phase III trial outcome

This morning, at the ASCO annual meeting, Dr. Charles Ryan will present the full interim results of COU-AA-302, the randomized, Phase III study of abiraterone acetate in chemotherapy-naive patients with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

New abiraterone data to be submitted for presentation at ASCO in June

We are now able to confirm that the full results of the Phase III trial of abiraterone acetate + placebo in the treatment of men with chemotherapy-naïve, metastatic, castration-resistant prostate cancer are being submitted for approval … READ MORE …

Abiraterone acetate superior to placebo in chemotherapy-naïve men with mCRPC

According to a media release from Janssen Research & Development (a unit of Johnson & Johnson), an independent trial monitoring committee has advised the company to stop the randomized, Phase III clinical trial of abiraterone acetate + predisone compared to a placebo + prednisone in treatment of chemotherapy-naïve patients with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …