NICE fails to endorse treatment with radium-223 for mCRPC

In a less than entirely surprising move, the UK’s National Institute for Health and Care Excellence has rejected Bayer’s initial application for coverage of radium-223 (Xofigo) under the National Health Service. … 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 …

Final data on radium-223 in mCRPC published in NEJM

The final results of the Phase III randomized clinical trial of radium-223 in treatment of men with metastatic, castration-resistant prostate cancer (mCRPC) have just been published in the New England Journal of Medicine this morning. … 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 …

Drug sequencing and combination therapy with newer prostate cancer therapies

There is an interesting report on the OncLive web site of a lecture by Dr. Robert Dreicer given just a few weeks ago and dealing with the sequential and combination use of new agents like abiraterone acetate, enzalutamide and others for the treatment of advanced and progressive forms of prostate cancer. … READ MORE …

New data on new and newer drugs at the GU Cancers meeting

A whole host of new data on drugs like sipuleucel-T, enzalutamide, abiraterone, and others was available in the poster sessions at the Genitourinary Cancers Ssympisum in Orlando today. … READ MORE …

US FDA grants priority review for radium-223

The U.S. Food and Drug Administration (FDA) has granted a priority review for radium-223 dichloride in the treatment of men with castration-resistant prostate cancer (CRPC) and bone metastases. … READ MORE …

Bayer submits application for approval of radium-223 in Europe

Based on data from the randomized, Phase III ALSYMPCA trial, Bayer has today submitted a Marketing Authorization Application to the European Medicines Agency for radium-223 dichloride in the treatment of men with metastatic, castration-resistant prostate cancer (mCRPC).

“Novel drugs enhance — but complicate — prostate cancer treatment”

An article with the above title appears in a new issue of The ASCO Post, and is based on a recent presentation by Dr. William Oh (of Mount Sinai School of Medicine, New York) at a “Best of ASCO” educational meeting held in Boston earlier in the year. For those trying to understand how to think about future opportunities for the use of abiraterone acetate, enzalutamide, and radium-223 in advanced and metastatic forms of prostate cancer, this overview may be helpful.

Other significant news from the ASCO annual meeting

We apologize for the slight delay in getting to other notable news from the annual meeting of the American Society for Clinical Oncology. (Other elements of the rest of life interfered.) However, here is the keypoint summary with links to the relevant abstracts: … READ MORE …

The radium-223 expanded access clinical trial

Just a quick update to information about expanded access to treatment with radium-223 — the injectable form of radiation therapy currently being developed by Bayer Healthcare and Algeta. … READ MORE …

Expanded access trial in development for radium-223 chloride (Alpharadin) in mCRPC

We have heard from one of our contacts that Bayer Healthcare (presumably in combination with their business partner, Algeta) is initiating an expanded access (compassionate use) trial of injectable radiation therapy with radium-223 chloride (Alpharadin®) for men with metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Expert commentary on new drugs for mCRPC

A videotaped expert commentary by Dr. Johann de Bono on the Medscape Oncology web site (with transcript) discusses four therapies (three now approved in the USA) that have recently demonstrated a survival benefit in the treatment of metastatic, castration-resistant prostate cancer.

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