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Keytruda Off Label

Posted: Sun Aug 11, 2019 8:26 pm
by meatie
Could anyone tell me the names of the oncologists that treating MSS patients using Keytruda off-label?

Also, how do I go about asking our oncologist to consult other oncologists that are using keytruda off-label, without appearing to give orders to our oncologist?


Re: Keytruda Off Label

Posted: Mon Aug 12, 2019 11:10 am
by boxhill
To my knowledge, there are studies doing this.

ETA: sorry, I see that you have discussed trials on another thread.

Re: Keytruda Off Label

Posted: Mon Aug 12, 2019 4:00 pm
by WarriorSpouse

Remember, Doctors have the ability to use off label based on their own training and experience. They can be the first one to off label use (FDA Approved Drugs) without others to follow.

If Botox can be used to fight migraines, initially off label; Keytruda should be allowed if traditional methods and means have failed. Also, the FDA has recently approved things such as Keytruda as part of the "Right to Try" rules. The FDA has approved the drug, but clinical trials have not yet determined how good it is and its use for certain circumstances.

These two things should help your doctor make the best decision for your treatments.

Good Luck!

Re: Keytruda Off Label

Posted: Mon Aug 12, 2019 6:51 pm
by Pyro70
Hi Meatie,

Any doctor can prescribe a drug off label. The main question is what is the medical rationale?

If you are MSS unless you have a high (or at least intermediate) TMB there is no reason to think that Keytruda monotherapy will work.

However, I’m currently tracking about 10 patients that are taking the combo of Regorafenib and a PD-1 inhibitor off label (I assume they all see different oncologists) Most of them just discussed the results of the Regonivo trial with their oncologists and their doctors were willing to give it a shot. I discussed it with my oncologist and she was very willing to try it off-label, when I reach that point. I notice you currently are on Regorafenib. You could add Keytruda since like Nivolumab is a PD-1 inhibitor so in theory they should be interchangeable. But I’d recommend going with Nivolumab, because that’s the drug used in the Regonivo trial and because it seems BMS has been quite willing to give the drug for free to patients trying it off-label. I’d suggest discussing the abstract and poster I shared in the regorafenib immunotherapy thread with your oncologist and ask him to try Regonivo.

Hope that helps

p.s. I hope in 2-3 months that we’ll see the first scan results from the people I’m tracking using this combo. If we see some real world successes, I think that will give us a lot more confidence in this combo.

Re: Keytruda Off Label

Posted: Tue Aug 13, 2019 2:02 pm
by boxhill
Something you are going to need to consider is whether your insurance will agree to pay for off-label use. It's great if they will, and certainly the recent studies make it more likely.

If they refuse, you can try to get it free or at reduced cost from the manufacturer.

I know that the projected cost of my roughly 2 year course of Keytruda is $240,000.