Yesterday, Johnson & Johnson announced that it has asked U.S. and European Union regulators to grant broader marketing approval for its cancer pill, Zytiga which is used to treat men with castrate resistant prostate cancer. Zytiga was approved in 2011 for the treatment of advanced prostate cancer in men who have received chemotherapy and who [...]
Medivation and Astellas Announce Initiation of Expanded Access Program for Enzalutamide (MDV3100) in the United States for men with metastatic prostate cancer previously treated with chemotherapy. Medivation, Inc. and Astellas Pharma Inc. today announced that they have come to an agreement with the U.S. Food and Drug Administration (FDA) which will allow them to proceed [...]
Xgeva (denosumab), which has already been approved by the Food and Drug Administration (FDA) for the prevention fractures in men with advanced prostate cancer that has already migrated to the bone, has been rejected by the FDA to expand the use of the drug to delay the spread of tumors in men without metastases to [...]
Historically, I have been critical of the FDA, especially around the delay of the approval of Provenge. Now, it is time to take a look at the FDA and what I believe the future will be for this agency. I do first need to make it clear that I do believe that the FDA plays [...]
Prior to the formal review, the FDA has raised questions about the ultimate approval of Amgen’s Xgeva (denosumab) for men with metastatic, advanced prostate cancer who have not yet developed metastasized to the bone. Xgeva has been shown to delay tumors spreading to bones, but it does not extend life, the holy grail of the [...]
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 [...]
