>>> In addition, the MOA of Gemzar supports efficacy <<<
Until efficacy of Gemzar is demonstrated in ovarian cancer ( still waiting ! ) , the MOA of Gemzar is much more supportive of causing cancer than curing it ( think about it ) , as is true of most chemotherapy agents and radiation therapy.
Until you have a specific regimen with proof of efficacy using these treatments , all you have is pretty K-M curves on surrogate endpoints , and loads of cash rolling in if you've been smart enough to bribe the right people.
It's hilarious to me how people railed about the possibility that scarce healthcare resources would be used on an untested treatment like Provenge , and how patients might be exposed to risks like CVAs for no reason , but happily accept that the same thing has occurred with Gemzar and other drugs.
Personally , I really have no problem with the Gemzar approval , given the lack of effective treatments for the condition , and I feel the same about AAs in general , for the most part. What is distressing to me is the total lack of logic and consistency in making the approval decisions , with Provenge being the ultimate example. The odds of Provenge providing a survival benefit , based on available data , are much better than the odds for Gemzar in ovarian , which are near zero , based on data on the label.
AI
