Today, Bayer supplied Malecare with an update about the status of the Xofigo shortage. Bayer has told us that they have identified the cause of the problem and have implemented a system to resolve the problem. They are hopeful that the first batch of drug will able to be released in the month of November, [...]
The Food and Drug Administration (FDA) is charged with protecting the general health and well being of Americans with medicines and certain treatment equipment. Sometimes these medications or treatment equipment fail, don't work as indicated or cause serious, life threatening side effects. Reporting these events is important so the FDA can track and monitor these [...]
Some good news for my European brothers, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adapted a positive opinion in support of the label expansion of enzalutamide (XTANDI) to include the treatment of men with metastatic castrate resistant prostate cancer (MCRPC) who are asymptomatic or mildly symptomatic after the failure [...]
In a poster presentation at the recent European Society of Medical Oncologists (ESMO) there was a very interesting poster presented updating a phase 3 clinical trial (CA184-043) which evaluated the overall survival (OS) with radiotherapy (RT) followed by either the immunologic drug Ipilimumab (Ipi) or with a placebo. This trial did not meet its endpoint [...]
Its day 20 since Xofigo production stopped. How are you? Please email Joel at joel@malecare.org about how the Xofigo shutdown has affected your life. Bayer has issued a public statement about the shortage of Xofigo (radium Ra 223 dichloride). After reviewing their statement I find that there is no new information that we haven’t already [...]
It would be of great advantage to us if we were able to improve the early detection of responders to salvage external beam radiotherapy (RT) after failed radical prostatectomy (RP). Early detection would allow us to make earlier treatment decisions which should provide for better results. In an attempt to better improve our understanding of [...]
The good news for us is that the survival of men diagnosed with prostate cancer has improved over time. The current 10-year relative survival rate is 99.7%! However, the long survival of men who have prostate cancer raises questions about their risk of a second primary cancer and the need for continued surveillance. A very [...]
A recent announcement stated that Dendreon’s immunotherapy Provenge (sipuleucel-T) is too expensive to be used as a treatment for advanced prostate cancer under the National Health Service in England. In preliminary draft guidelines out this morning, the National Institute for Health and Care Excellence has rejected the drug’s use to treat men with metastatic prostate [...]
The world wide supply of Xofigo (radium Ra-223 dichloride) available for patients will run out on October 10, 2014. Xofigo is the newly FDA approved treatment for men with castrate resistant metastatic prostate cancer (CRPC) with bone metastases without any known visceral metastases. Individual batches of drugs are inspected prior to release to patients. Bayer’s [...]
Oligometastasis can be described as a state of limited metastatic disease following failed primary treatment or even prostate cancer as it is first diagnosed. Many doctors believe that it is amenable to aggressive local therapy to achieve long-term survival. In a review designed to explore the role of ablative radiotherapy and surgical management of oligo-metastatic [...]
