FDA approves new form of abiraterone acetate for treatment of prostate cancer

On May 23, the US Food and Drug Administration apparently approved a new formulation of abiraterone acetate, known as Yonsa®, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). … READ MORE …

FDA approves abiraterone acetate for treatment of castration-sensitive, metastatic prostate cancer

Late yesterday the US Food and Drug Administration announced the approval of abiraterone acetate (Zytiga) + prednisone for the treatment of men with “high-risk, castration-sensitive”, metastatic prostate cancer. … READ MORE …

Might we see generic abiraterone acetate this year?

On Wednesday the U.S. Patent Trial and Appeal Board invalidated the last remaining patent on abiraterone acetate (Zytiga), making it possible that generic forms of abiraterone acetate would be available in 2018 (at least in the US). … READ MORE …

Radium-223 + abiraterone acetate: a potential safety issue

Bayer is to unblind data early from an ongoing randomized clinical trial of radium-223 acetate — on the guidance of the trial’s Independent Data Monitoring Committee (IDMC). … READ MORE …

What we DON’T know from the ASCO abstracts …

Near the end of last month we had told you that data from the LATITUDE trial and from Arm G of the STAMPEDE trial would be presented at the ASCO annual meeting in Chicago this year. … READ MORE …

Clinical effects of abiraterone acetate in the “real world”

It is well understood that drugs can demonstrate better results during the highly controlled, closely monitored setting of a clinical trial than they do in the “real world”. … READ MORE …

NICE approves use of Zytiga prior to chemotherapy

New guidance in England has expanded coverage of treatment with abiraterone acetate (Zytiga) + prednisone for men with metastatic castration-resistant prostate cancer (mCRPC). … READ MORE …