Long-Term Results of COU-AA-302 Show Abiraterone (Zytiga) Has A Survival Benefit

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 [...]

Bayer’s efforts to insure safety and restore Xofigo production

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 [...]

By |2014-11-04T11:47:17-05:00November 4th, 2014|Advanced Prostate Cancer, Xofigo|0 Comments

Bayer HealthCare Announces the Resumption of the Production of Xofigo (Ra 223 dichloride)

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. [...]

Outcomes Analysis of Pooled Individual Data from Randomized Clinical Trials of Degarelix versus Luteinising Hormone-Releasing Hormone Agonists

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 [...]

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