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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 [...]
Filed under: Living with Prostate Cancer, Management, Prevention, Treatment | Tagged: approval, denosumab, fracture, Prevention | Leave a Comment »
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:
Filed under: Drugs in development, Management, Treatment | Tagged: approval, benefit, FDA, risk | 9 Comments »
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.
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: abiraterone acetate, approval, Europe | Leave a Comment »
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.
Filed under: Drugs in development, Management, Treatment | Tagged: abiraterone, approval, Europe, Zytiga | Leave a Comment »
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.
Filed under: Drugs in development, Management, Treatment | Tagged: approval, biological, drug, EMEA, FDA | Leave a Comment »
We have already noted the FDA’s approval of abiraterone acetate. However, there are some interesting details that are worthy of note.
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment | Tagged: abiraterone, approval, survival, Zytiga | 2 Comments »
Rumors are circulating the the U.S. Food & Drug Administration might approve ipilimumab within the next few days for the treatment of metastatic melanoma. This approval could also offer opportunities for men with some forms of prostate cancer.
Filed under: Drugs in development, Management, Treatment | Tagged: approval, ipilimumab | 1 Comment »
According to a media release from Sanofi-Aventis, the European Commission has authorized marketing of cabazitaxel (Jevtana®) in all 27 countries of the European Union in combination with prednisone or prednisolone.
Filed under: Living with Prostate Cancer, Management, Treatment | Tagged: approval, cabazitaxel, Jevtana | 4 Comments »
According to a media release from Sanofi-Aventis and a report on the Reuters web site today, the European Medicines Agency (EMEA) has approved cabazitaxel (Jevtana)
Filed under: Drugs in development, Management, Treatment | Tagged: approval, cabazitaxel, EMEA, Europe, Jevtana | Leave a Comment »
Apparently the U.S. Food & Drug Administration (FDA) has canceled a meeting of the Oncology Drugs Advisory Committee (ODAC) that had been scheduled for February 9. The meeting was originally intended to discuss issues related to a biologics license application for ipilimumab (trade name Yervoy™).
Filed under: Drugs in development, Living with Prostate Cancer, Management, Treatment, Uncategorized | Tagged: approval, FDA, ipilimumab | Leave a Comment »
According to a company media release issued last Friday, Amgen has filed a second new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval of denosumab (a RANK-L inhibitor to be known commercially as Prolia®).
Filed under: Drugs in development, Living with Prostate Cancer | Tagged: Amgen, approval, denosumab, FDA, Prolia | Leave a Comment »
We reported last December that the Committee for Medicinal Products for Human Use had adopted a positive opinion and had recommended marketing authorization for degarelix, a second-generation LHRH receptor antagonist, for the treatment of patients with advanced, hormone-dependent prostate cancer. According to a media release from Ferring Pharmaceuticals earlier today, the European Union has now [...]
Filed under: Drugs in development | Tagged: approval, Degarelix | Leave a Comment »
Today’s important news reports address: 5- and 7-year survival data following iodine-125 permanent implant brachytherapy Risks associated with low levels of lymphocyte apoptosis in patients receiving radiation therapy Stiffening of the large arteries in men receiving antiandrogen therapy The status of the toremifene and denosumab applications for approval for marketing in the USA
Filed under: Drugs in development, Management, Treatment | Tagged: antiandrogen, apoptosis, approval, arteries, brachytherapy, denosumab, iodine-125, long-term, lymphocyte, radiation therapy, stiffening, survival, toremifene, toxicity | Leave a Comment »
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