Apalutamide (Erleada) approved in EU for treatment of nmCRPC

Yesterday, Janssen Pharmaceuticals announced the approval of apalutamide (Erleada) by the European Commission (EC) for the treatment of men with non-metastatic, castration-resistant prostate cancer (nmCRPC) who are at high risk for development of metastatic disease. … READ MORE …

Enzalutamide approved in Europe for treatment of chemotherapy-naive mCRPC

The European Commission has expanded marketing authorization for enzalutamide to include treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy and in whom chemotherapy is not yet clinically indicated. … READ MORE …

Expansion of indication for enzalutamide recommended in Europe

Late last week the Committee for Medicinal Products for Human Use (CHMP) in Europe recommended expansion of the marketing authorization for enzalutamide within member states of the European Union. … READ MORE …

A 13-year update from the ERSPC screening trial

So one of the presentations given at the recent EAU meeting in Stockholm was an update, by Dr. Jonas Hugosson, at a median 13 years of follow-up, from the European Randomized Study of Screening for Prostate Cancer (ERSPC)  — and there is some good news, but maybe not enough to get carried away by … yet. READ MORE …

Medivation/Astellas seek expanded indication for enzalutamide in Europe

According to a media release this morning from Medivation and Astellas Pharma, the companies have completed submission of data in support of the expansion of the European Marketing Authorization for enzalutamide — to include men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Dendreon to make sipuleucel-T available in Germany, the UK

According to a media release issued earlier today, Dendreon is planning to make sipuleucel-T (Provenge) available in Europe, beginning with Germany and the United Kingdom. However, the media release is short on any precision regarding the dates of such availability. … READ MORE …

Patterns of treatment of European patients with CRPC in 2009-10

The full text of an article by Sternberg et al. (originally published in BMC Urology in 2013) has just been published to the Medscape Oncology web site and addresses patterns of treatment of men with castration-resistant prostate cancer (CRPC) in five European nations before wide availability of abiraterone. … READ MORE …

EAU updates guidelines on screening, diagnosis, and management of localized prostate cancer

The European Association of Urology (EAU) has just updated its guideline document “EAU guidelines on prostate cancer. Part 1: Screening, diagnosis, and local treatment with curative intent”. … 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 …

Current issues related to management of advanced prostate cacner in Europe

According to an article on PharmaTimes Online, a new report issued in Europe suggests that "European healthcare systems are failing to deliver the latest medical breakthroughs to men with advanced prostate cancer." … READ MORE …

Zytiga approved in Europe for chemotherapy-naive mCRPC

As in the USA and some other countries, the European Union has now approved abiraterone acetate (Zytiga®), in combination with prednisone or prednisolone, for the treatment of men with chemotherapy-naive, metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

CMPH recommends expanded indication for abiraterone in mCRPC … before chemotherapy

According to a summary statement of opinion issued yesterday by the Committee for Medicinal Products for Human Use (CMPH) of the European Mediciens Agency (EMEA), CMPH is recommending an expanded indication for the clinical use of abiraterone acetate in men with metastatic, castration-resistant prostate cancer (mCRPC). … 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 …