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NICE Reverses Its Decision and Now Recommends Radium-223 (Xofigo) For Men Who Have Had Chemotherapy

According to Prostate Cancer UK The National Institute for Health and Care Excellence (NICE) has released its second draft decision on the availability of radium-223 (Xofigo). Different from the original draft this draft recommends that radium-223 be made available on the NHS for men with advanced prostate cancer that no longer responds to hormone therapy [...]

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 [...]

Dendreon Files for Chapter 11 Voluntary Bankruptcy Reorganization – Production Continues

It was announced this morning that Dendreon (the manufactures of Provenge) has filed for voluntary Chapter 11 Bankruptcy. After having spoken with a representative at Dendreon I have learned that the company has been in negotiations with its creditors and agreed to voluntarily file for financial reorganization. The agreement that Dendreon has reached with their [...]

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 [...]

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 [...]

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