European Union

Enzalutamide (XTANDI) Now Approved in Europe for Men With Metastatic Castration-Resistant Prostate Cancer Who Are Chemotherapy-Naïve

On Dec 2, 2014 Astellas Pharma Europe Ltd announced that the European Commission (EC) has granted a variation that amends their marketing authorization for enzalutamide (Xtandi). Based on this amended authorization Xtandi is now approved in Europe for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic [...]

By Malecare|2017-10-19T10:47:41-04:00December 9th, 2014|Advanced Prostate Cancer, Drugs & Treatments, Enzalutamide (MDV-3100), European Union, General Information, Uncategorized, Xtandi|0 Comments

Provenge is Approved to Market in the European Union

It was announced today by Dendreon Corp. that the European Commission (EC) has granted marketing authorization for Provenge in the European Union (EU) for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. This final decision by the EC follows [...]

By Malecare|2017-10-19T10:49:27-04:00September 17th, 2013|Advanced Prostate Cancer, Drugs & Treatments, European Union, Provenge, vaccines|0 Comments

XTANDI (Enzalutamide) Has Been Authorized in the European Union (EU) for Advanced Prostate Cancer

The great news for for our brothers in Europe is that Xtandi (Enzalutamide) has been approved for use in the European Union (EU) for the treatment of men with metastatic castration-resistant prostate cancer whose disease has progressed on or after chemotherapy (docetaxel). Following the regulatory review process by the European Medicines Agency (EMA) and a [...]

By Malecare|2017-10-19T10:49:42-04:00July 5th, 2013|Advanced Prostate Cancer, CHMP, enzalutamide, Enzalutamide (MDV-3100), European Union, General Information, MDV3100, Politics of Cancer, Uncategorized, United Kingdom - England, Northern Ireland, Scotland & Wales, Xtandi|0 Comments

Provenge Comes Closer to European Union Approval for Men with Advanced Prostate Cancer

It was announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that PROVENGE® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or Sipuleucel-T) be granted marketing authorization in the European Union (EU), for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) [...]

By Malecare|2013-06-28T09:05:09-04:00June 28th, 2013|Advanced Prostate Cancer, CHMP, Drugs & Treatments, General Information, Provenge, Uncategorized, Understanding APC, vaccines|2 Comments

Dendreon Opens It First Clinical Trial in the European Union

On September 27th Dendreon announced that it has enrolled and started its first patient with metastatic advanced prostate cancer that is castrate resistanr in a European Union based clinical trial of Provenge. Finally, men in the EU can hope that in the near future that Provenge could become available to them. The trial is hoped [...]

By Malecare|2017-10-19T10:50:45-04:00September 30th, 2012|Advanced Prostate Cancer, Drugs & Treatments, Provenge, Uncategorized, vaccines|0 Comments