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 …

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 …

Xtandi beats out Zytiga in NICE evaluation in the UK

According to an article this morning on the PharmaTimes web site,  Astellas has convinced the National Institute for Health and Care Excellence (NICE) to recommend coverage of enzalutamide (Xandi) in chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Health Canada expands clinical indications for use of Zytiga in mCRPC

According to a media release issued by Janssen, Inc. (a division of Johnson & Johnson) earlier today, Health Canada has approved the use of abiraterone acetate (Zytiga®) + prednisone for the treatment of chemotherapy-naive patients with asymptomatic or mildly symptomatic, metastatic, castration-resistant prostate cancer (mCRPC).

CMPH recommends expanded indication for abiraterone in mCRPC … before chemotherapy

According to a summary statement of opinion issued yesterday by the Committee for Medicinal Products for Human Use (CMPH) of the European Mediciens Agency (EMEA), CMPH is recommending an expanded indication for the clinical use of abiraterone acetate in men with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

NICE recommends coverage of abiraterone acetate by the NHS

According to a media release issued today, the UK’s National Institute for Clinical Excellence (NICE) has issued final guidance recommending the use of abiraterone acetate in combination with prednisone or prednisolone as a treatment option for men with metastatic, castration-resistant prostate cancer (mCRPC) that has progressed on or after at least one cycle of treatment with a docetaxel-containing chemotherapy regimen.

NICE initially refuses to cover cost of abiraterone acetate for mCRPC

In an utterly unsurprising announcement from the UK, the National Institute for Clincial Excellence (NICE) has issued draft guidance in which it refuses to cover the proposed cost of abiraterone actetate. … READ MORE …