in my 8 years since diagnosis I’ve not seen or heard an ad for any prostate cancer drug. Now in the past few months I can’t pick up my tablet or turn on my tv without an ad touting Nubequa as my savior. My understanding is that it has a few specific applications and isn’t particularly better than generic abi in most cases.
What gives?
There's never been a randomized trial, and probably never will be. So far, Nubeqa is only FDA-indicated for two situations: (1) with docetaxel for newly diagnosed, metastatic PCa, and (2) non-metastatic, castration resistant PCa. But I've seen insurance approve it in other situations. We are lucky to have 4 second generation hormonals to choose from: abiraterone/Zytiga, Xtandi, Erleada, and Nubeqa.
Thanks. Your depth of knowledge is always appreciate
So we have a $300 drug and a $13,000 drug and there will never be a trial to see which is better, if at all. The worst side effect of my cancer will be when my head explodes trying to make sense if this.
LOL! If you were a pharmaceutical manufacturer, say Bayer (who makes Nubeqa),would you want to sponsor a trial of Nubeqa vs Erleada? It might be inferior, equal, or superior. If inferior, you will lose billions. If equal, you are no better off than you are now. The only way you come out ahead is if your drug is superior- but why take the chance?
In the case of Zytiga vs Erleada, they are both manufactured by Janssen, but abi is now generic. If you were them, would you want to take the financial risk of proving that brand name Erleada is no better than generic abi?
Maybe the Brits will one day do such a trial as part of STAMPEDE2? But the PATCH trial in the UK may change the entire landscape of ADT.
Well said. But isn’t that why we have government and universities. Pardon my cynicism, but I spent 17 years as a daily newspaper reporter and 30 as a litigation lawyer. In those years I learned on thing—if you want the truth, “Follow the Money.”
NHS in the UK runs STAMPEDE as a government project, which is why, if a comparative trial occurs anywhere, it will be there. In the US, NIH/NCI is the governmental sponsor of many of our top clinical trials. But they rely on the pharmaceutical mfrs to supply the drugs, and they won't do that if there is no potential financial benefit. NCI has never undertaken a comparative trial of drugs that I'm aware of.
The FDA can require a drug company to prove efficacy and safety compared to the standard of care. But they have not usually required a comparative trial. That said, docetaxel was tested against mitoxantrone, but mitoxantrone was already known to provide no survival benefit. Controversially, Pluvicto was not required to show a survival benefit against Jevtana.
Universities seldom finance clinical trials. They rely on corporate sponsors for grant money.
TA -- I've said it before, but I want to say again that I think your contribution to this forum is extremely valuable, and I am very grateful for the effort you invest in doing the research you do, and writing these posts -- and I would guess many others would agree. Thank you..................
Yes indeed, many many of us hugely appreciate your contributions TA! Thank you!
Any comments on the DEAR results presented at the latest ASCO that compared 'real world' results of daro, enza and apa?
But not abi?
The only way to know is if randomized men get one drug or the other. Retrospective "real world" analyses can't distinguish selection bias.
Thanks! You confirmed my initial thoughts.
After 3 strong arguments made by me , citing all the positives, and clinical data, of the P A T C H trial, my Oncologist insists it's dangerous and will cause cardio issues, and blood clots, and won't prescribe me the e2 transdermal patch. He insists the 4 years of adt, (with 0 vacations) has nothing to do with my deteriorating bone density. I'm in the Philadelphia- Reading Pa area. Is there anyone in this group that may have recommendations for another care team? I'm currently Penn Medicine, Abramson Cancer Center
Is that a "center of excellence?"
I don't know
I just read that term on here a lot. Seeing "Penn", I wondered.
see:
Maybe get a second opinion from Elizabeth Plimack at Fox-Chase.
thanks T A!
My husband had a recurrence of PCa December 2023 with a lesion on his spine and a couple lymph nodes deep in pelvis that are enlarged. He is still hormone sensitive. The lumbar lesion was treated with radiation-I think it was 5 sessions.
His oncologist is a PI in a stage 3 clinical trial of men who have metastatic PCa but are still hormone sensitive. In this past December, Stage 3 clinical trial indicated the Darolutimide:/Nubequa would be of value for men still hormone sensitive. Our insurance denied the claim. However, his oncologist dealt directly with Bayer and he's receiving Nubequa shipped to our home monthly for free. The whole appeal to insurance and the request to Bayer took about 3 weeks.
He's been taking Nubequa for 5 months and his PSA test in month 3 measured at .08. My only concern about Darolutimide is whether it's contributing to what I see as extreme fatigue. I have yet to convince him to email his MO about side effects and dosage. He has also been getting Firmagon injections since this past December.
It competes with Xtandi more than Abi, no?
Nubeqa is different from other antiandrogens in terms of chemical structure, and like Celebrex, it belongs to the class of compounds known as phenylpyrazoles!
To be clear: follow the money is a trueism. Comparing drug efficacy, high cost vs low cost, takes money, time, and skilled analysis. For the manufacturer there is no real benefit and only risk.Governments can spend money, like it's free, in things they see benefit for. But remember they too get their money from large doners. You can guess who.
As to Nubeqa: I have yet to see an ad on TV for it. AARP mag once.
Finally, I have been in Nybeqa for over two years and the result <0.02 psa.
High cost? My state and Medicare pay all but $20.00.
so it’s ok for government to pay Bayer for your meds, but not ok to fund research to see if the Bayer med is better than the low cost one. Don’t get your logic.
Cynical, Negative or pessimistic, of you to read into my comment something that was not there or implied. I would have no issues or problem if the govt were to spend money on a well planned study comparing Nubeqa to any other drug.
My logic, as you inferred, did not say the govt shouldn't pay for a study. I clearly said follow the money the govt spends on studies.
As to NUBEQA, I only have anecdotal experience using the drug. As has been, frequently and clearly stated, we are each different in actions, reactions, and results of treatments.
I wish you well and success in your life and treatments.
Apology if I misread your post. Seems we’re on tff he e same page.
I did what I’ve been told is the Stampede trial protocol. Doxataxel, Lupron , Nubeqa. I have mets in the LN only, so a light load. I’ve been extremely lucky in that my body responded very well to the treatment and my PSA has gone from 52 at diagnosis to 0.009. In my last CT scan, before I start RT, the radiologist reported “no convincing evidence of active disease”. So, that’s been my experience, thus far.
how long were you on Lupron prior to radiation?
I’ve had Lupron every 3 months for 10 months now. I’m planning to start RT in early September. I’ve been really super lucky so far with SEs. I’m hoping that I’m not pushing my luck too far.
luck is very underrated
Like yours mine has been exceptional
Started when I got # 366 in the Draft lottery in 1970s and it continues 😎
I would add that Nubeqa is unique in that it doesn't pass the blood/brain barrier, which is important for people like me for whom ADT treatments generally cause massive depression/suicidality.
I am just becoming aware of the mental S.Efects of ADT. I have always been even keeled but now I am experiencing manic/depressive states that seem to come out of nowhere.
Odd. I’m possibly getting some memory glitches, but hard to tell. Before the days of pdas I forgot everything. Now if it’s in the iPhone, I do it. Fatigue is an issue but exercise is keeping that at bay. But the odd part is people tell me I’m more mellow than before. Maybe the low T.
We can’t forget that we’re all getting older, and the year between 69 and 70 or 79 and 80 is just not like that bygone year from 49 to 50. Even without meds, things get worse every year.
That's cause they're trying to teach us how to spell ie...... N U B E Q A (they don't use a U following a Q, because they feel that they're already screwing U).........
Good Luck, Good Health and Good Humor.
j-o-h-n Sunday 07/09/2023 1:10 PM DST
I've seen the t.v. comercials too. The real story here is that metastatic prostate cancer cases are up 30 percent over a relatively short period in history, in the USA. So well-produced, mass market advertising suddenly pays.
PSA slooooowly rising.
PSA a cautionary tale
Hoping for some reassurance and insight
Father’s MO now recommending adding Zytiga
ADT+Abi dry mouth ideas?
