4 ms·
Please elaborate on what made it clear so long ago.
by lonnyk 14y ago
Please elaborate on what made it clear so long ago.
- losvedir 14y agoIt did very well in all its trials. To get approved for use in any indication a drug has to go through a number of clinical trials - a Phase 2 in a small group of patients and multiple Phase 3's in a larger group. And that's for one indication only. So a cancer drug might try to get approved for "4th line" use in some cancer, meaning the FDA says it's okay to use after 3 other drugs have failed. After some success there, the drug company might push to expand its label into 3rd line or front line treatment and sponsor more clinical trials to compare it to the drugs currently used at those times. I don't know what trial this article was talking about specifically, but there were a number of other trials abiraterone did spectacularly in beforehand. Unfortunately, I don't recall the specific data from years ago when I kept up with this stuff. Cancer drugs frequently "work", but just barely, stopping the progression of symptoms for a few months or so, and this is enough to get approved. On the other hand, you have Gleevec[1], which turned a certain variety of leukemia from invariably fatal to a death rate of just 1%. Its efficacy was noted early in the trials and got approved quickly. Similarly, abiraterone's efficacy showed clearly in the early trials, although it's somewhere in the middle of the spectrum between "barely efficacious" and Gleevec. [1] https://en.wikipedia.org/wiki/Imatinib https://en.wikipedia.org/wiki/Imatinib