relugolix ADT

[spencoid2]

I saw my oncologist yesterday and he mentioned regulix as a possibly better alternative to lupron or other ADT treatments. However it is not yet approved for use even though the clinical trial suggests it is a much better alternative.

I would very much like to try it because it would be a good way to test the theory that the theory that the lymph nodes that are showing as either PC metastasis or lymphoma (radiologist suggested that this is an atypical pattern for PC metastasis) in a recent axumin PET scan are in fact PC. I prefer to not get a 3 or 6 month Lupron shot if I can get the regulix instead. If my PSA does drop precipitously it would indicate that the lymph node enlargements and tracer uptake are due to PC not lymphoma. The only other way to determine which it is is by biopsy which for the particular lymph nodes is either very invasive or to be done by fine needle biopsy which may be inconclusive.

So I am really anxious to try relugolix but have no idea when or if it might be approved.

Anyone know anything about this and or interested in working to get it approved before we all are dead? I wrote to my congressperson and senators.

onclive.com/web-exclusives/....

[Tall_Allen]

Fast-track FDA approval is about 9 months. There is nothing you can do to get it approved faster.

[spencoid2 in reply to Tall_Allen]

Do you think this would be fast tracked? Is that the norm now? It is approved in Japan for uterine fibroids so I could change sex and go to Japan.

[Tall_Allen in reply to spencoid2]

LOL.

Myovant has submitted a New Drug Application. FDA only fast-tracks approval when it is a new drug for a life-threatening disease setting where there are no available drugs (e.g., like PARP inhibitors for BRCA+ PC). Approval is usually faster too when it is only an expanded indication when the drug has already been in use and there is known efficacy and safety. The manufacturer has to ask for fast-track status, and to my knowledge, that hasn't happened, nor would they be likely to get it in this case.

onclive.com/web-exclusives/....

Myovant is more likely to get FDA approval of Relugolix for uterine fibroids in 2020. When that happens, you will be able to pay for an off-label Rx, but insurance/Medicare will not cover it, and I'm sure it will be very expensive.

[Miccoman in reply to Tall_Allen]

For those without an account at onclive.com here's a link to a story on Relugolix with lots of clinical details: targetedonc.com/view/fda-ap...

This story does not mention fast tracking

My reading seems to indicate that the one pill would replace both my Lupron and Xtandi -- how great that would be for my quality of life and what a blow to my oncologist's pharmacy, considering the amount of kickbacks they get for the monthly Xtandi and quarterly Lupron prescriptions, something north of $3,300 a year just for me...

And I suppose this drug will also only be available from an oncologist's pharmacy, like Xtandi, requiring a short tether to their office unless they will ship (mine will not, he's already unhappy with the "measly" 2% return on his pharmacy's $1,000,000 a month billing and loathe for it to incur additional expenses). Another oncology practice I went to (and I stress the word practice) shipped the Xtandi across Florida from their pharmacy to wherever I was -- that was nice, but my doctor there (30-something Hispanic) was a homophobic asshole. At least I feel like my current doctor likes me.

[Tall_Allen in reply to Miccoman]

It replaces Firmagon or Lupron, not Xtandi

[Miccoman in reply to Tall_Allen]

Thanks!

[fmenninger in reply to Miccoman]

The phase 3 HERO trial with myovant’s Relugolix vs Lupron should have included a third arm in the trials. It does not compare also vs Degaralix. However, Oral Relugolix shows promise vs Lupron as data shows MACE is significantly less and could be a game changer.

[Miccoman in reply to fmenninger]

Thanks! I had to look up MACE (major adverse cardiovascular events), but it does look promising.

However I'm wondering if orchiectomy, castration, might be a better option for my quality of life if that would eliminate the need for Lupron or Relugolix. I will be discussing this with my oncologist in a couple of weeks.

I find that the fewer doctor visits I have, the happier I am. And after 6 years on Lupron, the boys aren't ever coming back, nor do I have any use for them even if they would. Plus one less co-pay is also a factor.