4 ms·
If someone over 25 gets it, then this method is not approved for them? That's how I read this.
by eatbitseveryday 9y ago
If someone over 25 gets it, then this method is not approved for them? That's how I read this.
- epmaybe 9y agoyou can get approval on a case by case basis, from what I understand. The doctor or institution will have to send a letter to the FDA beforehand though.
- refurb 9y agoThere is no need for physicians to inform the FDA about off-label use. It happens thousands of times per day.
- epmaybe 9y agoI think when I wrote this comment I forgot what we were talking about. I was thinking about drugs currently being used in clinical trials. My mistake
- refurb 9y agoYou are correct about the compassionate use/early access program where patients take drugs prior to FDA approval. All of that needs to be done in concert with the FDA.
- ceejayoz 9y agoThat's my understanding. Generally, that means they don't have enough data on the non-approved ages from clinical studies yet. Would make sense, given it's considered a childhood cancer - they'd do trials on children first.
- refurb 9y agoI'm guessing there were no patients over 25 in the trial? Yes, patients older than 25 can still get it as physicians are allowed to prescribe off-label. Whether insurance will pay for it is another question.
- HillaryBriss 9y agoi'm surprised it actually is a question. i would have thought there was no question at all and that the answer was just no. does anyone truly have health insurance with benefits this high?
- refurb 9y agoInsurance pays for off-label therapies all the time and oncology it's very common.