Replies to post #111489 on Biotech Values

[poorgradstudent]

>I believe you - but I don't get it.<

One random tidbit I've picked up over the years is that the FDA's stance towards oncology appears to be substantively different than for other indications.

So your stance is perfectly compatible with the oncology approval pathway, and I identify with it. But the oddity is that for non-lethal conditions (for lack of a better term), the FDA appears to allow multiple challengers in similar classes. These RA drugs are examples, as well as the cholesterol modifying agents... those didn't necessarily go head to head either.

I'm not sure exactly what the line of demarcation is for the apparently different attitudes of the FDA, but they certainly seem more flexible in certain indications than others.

[biomaven0]

would at least have had to pass a non-inferiority trial

The FDA mandate is to approve drugs that are (1) safe and (2) effective. It's fine (and much more straightforward) to show "effective" against a placebo, as you don't have the uncertainty about the effectiveness of the comparator drug to worry about.

The problem comes when you can't ethically use a placebo at all, such as in antibiotic trials for serious infections. Then you have to resort to non-inferiority trials.

In oncology, one trend has been to use the new drug as an "add-on" to existing therapy - so the trial is new drug + existing drug vs. placebo + existing drug, and the trial will attempt to demonstrate superiority.

The FDA only really gets into drug comparisons when there are safety concerns surrounding the potential new drug. Technically that's beyond their purview, but the new de facto standard seems to be if the new drug isn't an advance over existing drugs and has safety concerns, they find a way to turn it down.

Peter