NICE, abiraterone, and the economics of treatment

On Friday last week the National Institute for Health Care Excellence (NICE) in England came to the conclusion that abiraterone acetate (Zytiga) is not cost-effective in the treatment of men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC), based on the most recently proposed price to the National Health Service. … READ MORE …

How NOT to get your technology approved rapidly by the FDA

In a second statement to the media since an advisory panel to the U.S. Food and Drug Administration (FDA) decided not to recommend approval of EDAP TMS’s outdated form of Ablatherm technology for the treatment of low-risk prostate cancer, the company’s CEO seems to exhibit serious misunderstandings about how to work with the FDA. … READ MORE …

A seminal event in cancer drug development

Last week we saw a striking event in the history of cancer drug development. It wasn’t related to a drug for the treatment of prostate cancer, but it was important nonetheless, and it shows what may become possible in prostate cancer in the future. So what happened? … READ MORE …

Making drug approval data more “patient centric”

Many of our readers may be interested in an opinion-piece by Dr. Ethan Basch in this week’s issue of the New England Journal of Medicine. … READ MORE …

Provenge likely to be approved in Europe later this year

The European Medicines Agency’s Committee for Medicinal Products for Human Use today recommended that marketing authorization be approved for sipuleucel-T (Provenge) in the European Union. A final decision by the European Commission is likely later this year. … READ MORE …

European regulators approve enzalutamide for treatment of mCRPC

Yesterday, the European Commission approved the use of enzalutamide (Xtandi) for the treatment of metastatic, castration-resistant prostate cancer (mCRPC) in men who have progressive disease after at least one cycle of docetaxel-based chemotherapy. … 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).

FDA approves clinical use of cabozantinib (but not for prostate cancer, yet)

The U.S. Food & Drug Administration (FDA) has approved cabozantinib (brand name Cometriq™) for treatment of progressive, metastatic medullary thyroid cancer in the USA. … READ MORE …

FDA sets “action date” of November 22 for MDV3100

According to a joint media release issued by Medivation and Astellas Pharma, the US Food & Drug Adminstration (FDA) has informed Medivation that the Prescription Drug User Fee Act (PDUFA) action date for the review of the new drug application (NDA) for enzalutamide (also known as MDV3100) will be November 22, 2012. … READ MORE …

FDA expands approval of denosumab in men with advanced prostate cancer

According to a media release issued by Amgen earlier today, the U.S. Food & Drug Administration (FDA) has approved denosumab (marketed as both Prolia® and Xgeva®) as a treatment to increase bone mass in in men with non-metastatic prostate cancer who are already being treated with androgen deprivation therapy (ADT) and who are at high risk for bone fractures. … READ MORE …

What FDA drug approval does and does not mean

If you are among the people in America who agree with one or other of the following two statements, you need an immediate crash course in what approval of a new drug by the U.S. Food & Drug Administration (FDA) does actually mean: … READ MORE …

European Commission approves abiraterone acetate for mCRPC

Abiraterone acetate (Zytiga®) has been approved for clinical use in European Union nations, according to a media release from Johnson & Johnson issued earlier today. This final approval by the European Commission follows an earlier recommendation for approval issued by the European Medicines Agency (EMEA) at the end of July. … READ MORE …

EMEA approves abiraterone acetate for treatment of mCRPC

Last Friday the European Medicines Agency (EMEA) gave approval for the marketing of abiraterone acetate (Zytiga™) for the treatment of metastatic, castration-resistant prostate cancer in men who have already progressed after treatment with docetaxel-based chemotherapy. … READ MORE …

FDA does a pretty good job of approving new drugs to treat cancer

It is common to hear people complain that the U.S. Food & Drug Administration (FDA) takes too long to approve new cancer therapies or that new drugs are brought to market much sooner in Europe than they are in America. A new and independent assessment of the facts actually suggests quite the opposite. … READ MORE …

FDA approval of abiraterone: some interesting notes

We have already noted the FDA’s approval of abiraterone acetate. However, there are some interesting details that are worthy of note. … READ MORE …