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 …

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.

An update on the shortage of radium-223 (Xofigo)

On October 21, here in the USA, Bayer HealthCare Pharmaceuticals issued a Dear Healthcare Professional letter to medical professionals indicating that the company still does not know when it is likely to be able to start to re-supply this radiopharmaceutical agent for the treatment of late-stage prostate cancer. … READ MORE …

Global shortage of radium-223 (Xofigo)

Apparently a problem in the manufacturing process for radium-223 dichoride (Xofigo) at the only plant where the drug is made (in Norway) has required that the plant be temporarily shut down. The supply of radium Ra-223 will run out tomorrow (October 10, 2014) for all current and new patients, worldwide. … READ MORE …

Bayer to acquire full ownership of radium-223

According to a report on the MarketWatch web site this morning, Bayer AG’s acquisition of Algeta will be completed before the end of March this year, at which time Bayer will become the sole owner of radium-223 (Xofigo) with full responsibility for the future development and marketing of this drug currently indicated for the treatment of late stage prostate cancer.

“Top pick” focuses on advances in treatment of mCRPC

In a new article on the Practice Update web site, Dr. Howard Scher, an oncologist specializing in treatment of advanced prostate cancer at Memorial Sloan-Kettering Cancer Center in New York, writes about his “top pick” regarding new prostate cancer knowledge from 2013. … READ MORE …

EC gives marketing approval for radium-223 in metastatic CRPC

We understand that, earlier today, the European Commission (EC) approved radium-223 dichloride (Xofigo®) for the treatment of men with castration-resistant prostate cancer (CRPC), symptomatic bone metastases, and no known visceral metastases. … READ MORE …

US FDA approves radium-223 dichloride for treatment of men with mCRPC

The “New” Prostate Cancer InfoLink apologizes for a delay in letting readers know that on Wednesday the US Food & Drug Administration approved radium-223 dichloride (Xofigo®) for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, but no known visceral (i.e., soft tissue) metastases. … READ MORE …