When the FDA approved Abiraterone with prednisone (Zytiga) in the pre-chemotherapy stage they approved it after an interim analysis of data was performed of the phase III clinical trial (COU-AA-302), The analysis was performed by an independent data monitoring committee that found a significant difference in radiographic progression-free survival (scans that showed no tumor progression [...]
Malecare received more detail from Ms. Gissoo Decotis, Deputy Director of Oncology Advocacy Relations Bayer HealthCare, LLC. The following is about Bayer's efforts to insure safety and get Xofigo back into the market. "Following extensive root cause analyses, corrective actions at the manufacturing site were put into place. These actions included isolation of the affected [...]
Bayer HealthCare has announced that they have now resumed production of Xofigo (Ra 223 dichloride). Bayer has indicated that an initial lot of Xofigo has already been released so some patients will be able to re-start their treatment as early as this week. Bayer is in the process of contacting treating physicians with the news. [...]
Not all of us can or even want to grow mustaches. And even fewer of us want to bother our friends and neighbors about foot races or fundraising schemes. BUT>>> All of us eat food. Even guys diagnosed with prostate cancer eat food. When you’re diagnosed with prostate cancer, chances are that you think a [...]
Degarelex (Firmagon) (approved by the FDA in December of 2008) is a hormonal therapy drug used to treat advanced prostate cancer that has become metastatic and castrate resistant (mCRPC). Degarelix is a GnRH receptor that binds to the pituitary GnRH receptors, reducing the release of gonadotropins leading to a quick and profound onset that blocks [...]
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 [...]
Something we hope our prostate cancer won't cause to our loved ones. Eventually is a collection of first person video testimonials about significant loss and bereavement. In each account, participants reflect upon their own experience, recount events leading up to and around the death of their family member or loved one, talk about how they [...]
According to an article in today’s USA Today, many more doctors will not be accepting medical insurance plans offered through Affordable Care Act exchanges. The reason cited is that these plans often have lower reimbursement rates than the commercial plans. The article indicated that “some doctors are limiting how many new patients they take with [...]
Day 25 of Xofigo shutdown. We're hearing from men who have lost the opportunity to continue their treatment on schedule. We're hearing from deeply worried spouses. We want to hear from you, too. Malecare continues to investigate. Malecare contacted factory workers at the Bayer plant in Norway. Predictably, they wouldn't answer Malecare's questions about when [...]
