Quicker Approval?

Yahoo had a story about the FDA's "Breakthrough" status, providing a little more background about how and why it all plays out. I think it's important -- not just because the FDA status will help more people, but also because of what it says about the effectiveness of treatments.

According to Yahoo, more treatments are getting Breakthrough status because they are showing so much success in phase 1 clinical trials.  Phase 1 trials used to be focused on whether or not a particular dose would be safe. Now, because of genetic testing and treatments that target particular genetic traits, we can see real results from phase 1 trials. In other words, if we know that a treatment will likely target one particular version of Follicular Lymphoma, and a patient has been tested to show that he has that version, and the trial includes only patients with that version, then we'll get a pretty good picture right off of whether or not that treatment will be successful.

That's great news for the patients in trials with potential Breakthrough status, and for patients with conditions that meet those criteria and could benefit later.

But it seems like great news for the rest of us, too. If we have enough potential Breakthrough treatments  that Yahoo is getting excited about it, it means that genetic testing is advancing far enough that more and more treatments might be developed based on genetics.

This is the kind of personalized medicine that we've been promised for a few years: knowing enough about the tiniest details of a person's cancer to know which treatments are likely to work.

Granted, there's lots of work to still be done -- even with genetic testing, no treatment is 100% guaranteed -- but it's a definite step in the right direction.