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 …

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 …

Repeated treatment with radium-223 after a first treatment cycle

Radium-223 or Xofigo was first approved in 2013 as “an alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.” That meant (and still means) one course of treatment with six cycles of radium-223. However, … READ MORE …

Combination therapy with radium-223 and abiraterone acetate in mCRPC

We understand from the manufacturers that the so-called ERA-223 trial — a randomized, double-blind, multi-center, Phase III trial of radium-223 acetate (Xofigo) + abiraterone acetate (Zytiga) + prednisone compared to a placebo + abiraterone acetate + prednisone — is now fully enrolled. … READ MORE …

NICE recommends coverage of radium-223, but …

According to a recent report in Pharma Times, the National Institute for Health and Care Excellence (NICE) in the UK is recommending coverage of treatment with radium-223 dichoride (Xofigo) but has changed its mind about coverage of degarelix (Firmagon). … READ MORE …

New plant in USA for manufacture of radium-223 dichloride (Xofigo)

According to a joint media release issued earlier today, Bayer HealthCare and Cardinal Health have signed a 15-year agreement for the contract manufacturing of Xofigo® (radium-223 dichloride). … READ …

Another Bayer, radium-223 (Xofigo) update

According to information on the Malecare Facebook page, Bayer is hoping to be able to re-start manufacturing of radium-223 at their plant in Norway at some time in November. However, no specific date has been provided for product availability, as yet.