We are about to finally get a more formal presentation of the great news we have all been waiting to hear. Medivation Inc. and Astellas Pharma Inc. announced that data from their Phase 3 AFFIRM trial, evaluating MDV3100 in men with advanced prostate cancer, will be highlighted in a late-breaking oral presentation at the upcoming [...]
Amgen (NASDAQ: AMGN) today published a press release that said the U.S. Food and Drug Administration (FDA) will target an action date of April 26, 2012 for the supplemental Biologics License Application (sBLA) (approval) to expand the indication for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer with the goal of reducing the risk [...]
Amgen has submitted a supplemental Biologics License Application (sBLA) to the FDA to expand the indication for denosumab (XGEVA) its RANK ligand inhibitor to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, denosumab would be the first therapy licensed to prevent or delay the spread of cancer [...]
Yesterday, Amgen announced that it had submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) to expand its license for XGEVA® (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases. If approved, XGEVA would be the first therapy licensed to prevent or [...]
The FDA approval of Zytiga (abiraterone acetate) for men with advanced prostate cancer defines the men who qualify to receive the drug. To qualify you must have advanced prostate cancer and meet all of the three criteria below: 1- Men who are metastatic. 2- Men who failed hormone therapy also known as castrate resistant or [...]