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 …

ENZAMET trial results to be presented at ASCO

The results of the 1,125-patient, randomized, double-blind ENZAMET trial are to be reported in a late-breaking abstract at the upcoming annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago. … READ MORE …

Long-term follow-up data from LATITUDE trial

Long-term follow-up data from the LATITUDE trial have now been published by Fizazi et al. in Lancet Oncology. … READ MORE …

Phase III trial of olaparib in first-line treatment of mCRPC

Unfortunately we don’t always hear about some interesting clinical trials as early as we would like to. The following is a case in point. … READ MORE …

Cardiovascular history, abiraterone acetate, and 6-month mortality rates

In a not entirely surprising set of findings, data from a relatively large registry study — to be presented at an upcoming meeting of the American Association of Cancer Research (AACR) — suggest that treatment with abiraterone acetate raises risk for cardiovascular-related mortality among prostate cancer patients with known cardiovascular risk factors. … READ MORE …

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 …

Results of PLATO trial published in JCO

The results of the PLATO trial have just been published in the Journal of Clinical Oncology (JCO). … 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 …

Low-dose abiraterone with food proves its worth in small Phase II trial

We have known for some time that taking abiraterone acetate (Zytiga) with food (as opposed to on an empty stomach) might well allow patients to be able to take significantly lower doses of this product and gain the same clinical benefit as is currently known to be beneficial from taking 1,000 mg/day when fasting. … 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 …

Abiraterone acetate vs. enzalutamide: a head-to-head study in men with CRPC

Apparently a group of Japanese researchers determined a while ago that we need to know whether abiraterone acetate (Zytiga) or enzalutamide (Xtandi) is the better drug for first-line treatment of chemotherapy-naive patients with castration-resistant prostate cancer (CRPC) — whether it is metastatic or non-metastatic in type. … READ MORE …