This has been an interesting year as men with advanced prostate cancer have seen three different drugs approved. Considering that the prior six years did not have any new drug approvals, this has been a stellar year. First we had Provenge approved, then came Jevtana and now we have added to the list Xgeya (denosumb). [...]
In order to get FDA approval, drugs must first go through a clinical trial that demonstrates that they offer a better treatment result than the current standard of care. In some instances the better result can be a demonstration that the investigational drug provides an advantage which is only palliative (as Mitoxantrone does for advance [...]
Although some people have called it intriguing, a new “On The Horizon” drug, XL-184, is still very early in its testing. What makes LX184 intriguing is the just released results from a conference in Berlin. In very early testing, 19 of 20 men in a phase I trial showed an improvement in their scans used [...]
Today, I spent most of the day listening to the CME (Medicare & Medicaid) hearing on Provenge. CME does not have to abide to the decisions of the advisory committee, so like we experienced with the FDA Advisory Committees we will have to wait and see what will eventually become the policy for reimbursement. I [...]
Since the approval of Provenge in April of 2010 the pipeline of new potential immunotherapy drugs has swelled. For excellent reasons, many of us are very optimistic about the future. […]