Court invalidates patent on J&J’s Zytiga, but …

Here in the US, according to news reports issued late on Friday, a federal court in New Jersey invalidated the last remaining patent held by Johnson & Johnson on their formulation of abiraterone acetate, known as Zytiga, and used in the treatment of castration-resistant forms of prostate cancer. … READ MORE …

Using low-dose abiraterone acetate with food (or a standard dose with no food)

We have known for some time that abiraterone acetate 250 mg, when given with food, appears to have activity that may — in at least some patients — be comparable to the activity of abiraterone acetate 1,000 mg given without food. … READ MORE …

Xofigo (radium-223 acetate) should NOT be used in combination with abiraterone acetate

In December last year we noted an announcement by Bayer that the company was unblinding data from an ongoing clinical trial because of a potential safety issue when radium-223 (Xofigo) was given in combination with abiraterone acetate + prednisone. … READ MORE …

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 …