HOW GOOD IS DAROLUTAMIDE?

[yeatz]

March 16, 2021

From Yeatz:

Hi, friends! Quick update & a question: Been fighting PC for 7 years; had radiation plus ADT; then recurrence (Gleason 8;high-risk). Now on chemo (plus ADT). Abiraterone didn't work; having good luck with Docetaxel. Have metastases in lymph nodes; bones clear so far.

Docetaxel has run its course. Anti-receptor is next. MO wants old standby, Enzalutamide. But I've read highly complimentary stuff about new AR, Darolutamide. Ideal chemical structure; fights receptors in two ways instead of one. Also very few side effects, especially in central nervous system; goes through blood-brain barrier only one-fifth as much as Enzalutamide.

Darolutamide was approved by FDA for patients with no metastases. But I've found that federal law requires Medicare coverage of off-label use of cancer drugs -- doesn't even have to be same type of cancer! (Cancer & treatment take such weird paths that FDA gives lots of leeway.)

So: I'd like to go with Darolutamide. Have any of you taken it? Results? I'd be very grateful to know your experiences with it. Would help a lot with my decision -- and how hard to fight with my MO!

Many thanks,

yeatz

[Tall_Allen]

These are the Medicare rules from 2009 - have they changed?

ncbi.nlm.nih.gov/pmc/articl...

If not, it would have to be listed as "recommended" for that indication in one of the approved drug compendia or you would have to submit evidence from a peer-reviewed study.

You may have more luck if you make a case with your Part D insurance that none of the alternatives are viable to you, or getting the mfr to supply it under "expanded access" if there are no alternatives:

fda.gov/news-events/public-...

[Blueslover]

It brought my PSA down to undetectable again after Lupron have up the ghost. No side effects that I can detect

[yeatz in reply to Blueslover]

Thanks for your input. I hope, if I use it, things will turn outas well for me!

[yeatz]

I'm concerned about other drug companies trying to push out Daro.I was a newspaper reporter for 40 years before I retired; maybe I should

get back into digging. Do you have any more info, especially specifics -- which

companies are involved, what exactly are they doing, is Bayer fighting back,

etc.?

[John438]

I’ve been taking darolutamide for 6 months now and it is amazing. My PSA had gone up to 18 and I was a little worried about going back to Lupron. So my oncologist started daro and in 3 months it dropped to 0.37. I also just got out of the hospital for another problem and they wouldn’t let me take it, so after 3 weeks on not taking it went to 0.74 Not bad and we expect it to go back down in the next 3 months. Also the only side effect I’ve had is fatigue nothing else to report.

[teacherdude70]

Darolutamide, Nubeqa, is approved/paid for by Medicare part D.I am now on my 4th month on it after Lupron failed and my psa rose to 1.78.

Dropped first month to 0.60 and then 0.06. Now it is 0.04.

No issues with side effects. Low energy? Yup. But hit the gym 3-5 times a week and do carpentry, yard work, and gardening. Might work 20 min with 20 off but get by it.

Hot flashes less often but hotter.

I support this med! Must say first month free but could be kind of expensive until you get past the donut hole. My pharmacy linked me up with financial help so was not bad. Actually only $10/month and well worth it.

PM me for more if you like.