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ARSI PR wars: Nubeqa (Bayer) vs Erleada (J & J) lawsuit
We're caught in a lot of marketing crossfire these days.
Bayer keeps trying to scare us into thinking Nubeqa is safer than Erleada because it doesn't cross the blood-brain barrier (BBB), and has even started an expensive ad campaign with Tony Romo to convince us that Nubeqa is the only choice for "Men who want to keep their heads in game." Unfortunately for them, an independent large-scale retrospective study has just concluded that the theoretical benefits of Nubeqa's not crossing the BBB don't translate to real-life cognitive benefits: https://www.urotoday.com/conference-highlights/suo-2025/suo-2025-prostate-cancer/165194-suo-2025-real-world-assessment-of-new-onset-central-nervous-system-conditions-in-patients-with-non-metastatic-castration-resistant-prostate-cancer-treated-with-apalutamide-darolutamide-or-enzalutamide.html
Meanwhile, Johnson and Johnson have released a restrospective study of their own, suggesting that Erleada has a 51% lower risk of death after 2 years than Nubeqa. Methodological issues aside — and they're non-trivial — it's misleading because it's 51% of a very small number: most patients with metastatic castrate-sensitive prostate are still alive after 2 years of doublet therapy, regardless of which ARSI they're using:https://www.urologytimes.com/view/head-to-head-analysis-shows-os-benefit-with-apalutamide-vs-darolutamide-in-mcspc
Nevertheless, to save their ad campaign, Bayer has launched a big lawsuit against J&J, (rightly) challenging the methodology, but mainly just picking keywords to ensure that anyone doing a web search will find stories about their lawsuit rather than J&J's study: https://www.fiercepharma.com/marketing/bayer-sues-jj-over-deeply-flawed-promotional-claims-touting-erleada-over-nubeqa
I'd suggest ignoring both companies' dubious secondary marketing claims (the supposed cognitive advantage for Nubeqa, and the supposed survival advantage for Erleada), and just keep on keeping on with whichever -lutamide works for you (or even older Zytiga, if you can tolerate the steroid you have to take with it). They truly are all miracle drugs, despite the smarminess of the companies that sell them. ❤️
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Whether or not darolutamide passes the blood brain barrier and causes less brain fog is a factor that can be considered. darolutamide does have one major advantage. The side effects from darolutamide are much milder for many people than those from apalutamide or enzalutamide. Many people have fatigue from those two products, but darolutamide seldom causes that.
I don’t think there’s much difference in effectiveness. If people have no problem with the side effects of a drug, then it’s just fine for them.
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1 ReactionThey each have their safety profile.
It’s always difficult to extrapolate from a large population to what the outcome will be for one individual.
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2 Reactions@brianjarvis
I’ve heard from dozens of people that are on Nubeqa, I don’t think I’ve heard of fatigue being a problem more than once. In that case, it was somebody who stopped taking it and then started it again. Interesting that i’ve heard about fatigue from the other drugs, but it’s listed as less than 1%. Also interesting that Nubeqa is supposed to work better if you’re on chemo.
All of the side effects seem to affect less than 1% of the people using the drug, except cardiovascular with less than 4%.
The rash issue seems to be common among all of them. I have small little rashes all over my stomach really small. I have three or four spots where the skin turns a little brown and it’s itchy. I figured it had to be Nubeqa. I have to put Triamcinolon on three spots almost every day or it starts to itch. Fortunately, my dermatologist has allowed me to order this repeatedly.
Interesting tables.
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1 ReactionI suspected this: seems Nubeqa has been poaching a large number of PC patients who didn tolerate Erleada..J&J ( who makes Erleada) decided to scare them straight..
'Bayer has filed a lawsuit against Johnson & Johnson (J&J) in a Manhattan federal court, accusing the company of false advertising regarding claims that its prostate cancer drug Erleada is superior to Bayer's Nubeqa. The lawsuit, filed in February 2026, alleges that J&J’s marketing campaign—which boasts a 51% reduction in the risk of death with Erleada compared to Nubeqa—is based on "flawed" real-world evidence.
Bayer
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Key Aspects of the Dispute:
The Claim: J&J (via Janssen) announced in early 2026 that a real-world, head-to-head study of men with metastatic castration-sensitive prostate cancer (mCSPC) showed a 51% reduction in the risk of death for Erleada patients compared to Nubeqa over 24 months.
Bayer's Position: Bayer argues that the data used by J&J is not a proper, well-controlled clinical trial but rather a "retrospective, real-world data review". Bayer contends this analysis is "riddled with problems" including significant selection bias, unequal cohort sizes (with 1,460 Erleada patients compared to 287 Nubeqa patients), and improper accounting for comorbidities.
Methodological Issues: Bayer claims that for 97% of the time period used in J&J’s analysis, Nubeqa was not approved for monotherapy (use without chemotherapy), which invalidates the comparison against Erleada. Furthermore, Bayer alleges the study did not actually follow patients for a full 24 months as claimed.
J&J's Response: J&J has defended its study, stating it stands by the "rigor and integrity" of its analysis and argues that Bayer’s lawsuit shows a "misunderstanding of methodological frameworks and real-world evidence principles".
Legal Action: Bayer is seeking an injunction to stop the marketing campaign, along with damages and corrective statements.
The lawsuit highlights the increasingly intense competition in the prostate cancer market and the rising use of "real-world evidence" to make superiority claims in advertising. '
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5 ReactionsYes. The interesting thing is that a big study (not from J&J) just came out contradicting Bayer's claim that Nubeqa causes fewer cognitive issues (like brain fog) than other -lutamides. J&J could have leaned into that instead of pushing their own hastily-assembled study:
https://www.urotoday.com/conference-highlights/suo-2025/suo-2025-prostate-cancer/165194-suo-2025-real-world-assessment-of-new-onset-central-nervous-system-conditions-in-patients-with-non-metastatic-castration-resistant-prostate-cancer-treated-with-apalutamide-darolutamide-or-enzalutamide.html
Of course, any individual patient might do better on one -lutamide than another, but AFAIK, this is the first big real-world assessment (RWA) that looked at whether Nubeqa's hypothetical benefit actually panned out in real life.
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2 ReactionsFor those who don't want to skim the whole article linked in the previous post, here's the core finding ("CNS" == central nervous system):
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The new-onset rates for commonly observed CNS effects were as follows:
Apalutamide (n=253):
Fatigue: 7.5%
Falls: 6.7%
Pain: 5.1%
Dizziness: 5.1%
Weakness: 3.6%
Headache: 3.2%
Darolutamide (n=544):
Fatigue: 7.9%
Falls: 10.3%
Dizziness: 6.1%
Pain: 5.7%
Weakness: 5.3%
Enzalutamide (n=645):
Fatigue: 9.6%
Dizziness: 5.1%
Pain: 9.1%
Falls: 5.1%
Weakness: 6.7%
Across all categories, apalutamide consistently demonstrated the lowest or near-lowest rates of new-onset CNS effects, with enzalutamide demonstrating the highest rates for many events.
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https://www.urotoday.com/conference-highlights/suo-2025/suo-2025-prostate-cancer/165194-suo-2025-real-world-assessment-of-new-onset-central-nervous-system-conditions-in-patients-with-non-metastatic-castration-resistant-prostate-cancer-treated-with-apalutamide-darolutamide-or-enzalutamide.html
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3 ReactionsHonestly, I wouldn’t trust anything J&J has to say about any of their drugs or their research.
Over the years, their drugs and medical devices have killed more people than the tse-tse fly.
If you read the book ‘NO MORE TEARS’ you will shake with rage at their blatant lies - and the enablers paid handsomely to keep them going. Thanks for the post!
Phil
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3 Reactionsmy 2 cents: last July, I was prescribed Orgovyx and Erleada together...I took both about 3 weeks...over 5 weeks, I went to the ER 3 times from the horrible side effects ( heart palpatations, nausea, fatigue, appetite loss) ...finally, my RO suggested I drop Erleada ( funny how these drugs have an ethnic name ring to them )..at any rate, I stopped everything for about 10 days.. then went back on Orgovyx and finally, oncology team /insurance approved Nubeqa...and since then, no real problems with tolerating the two drugs..and so far, PSA has dropped dramatically from 61 to < .01- in about 5 months. SO for me, Nubeqa was dramatically better...I suspect both work very well, but you cant take what you cant tolerate, right ?
Now, going on 8 months, Hot flashes are really main side effect followed by some transient fatigue and sleep issues at times.
( thanks to Jeff Marchi for suggesting Nubeqa as alternative-I would have never known to ask for it)
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6 Reactions@xahnegrey40 and @northoftheborder, I merged your 2 discussions on the same topic into this discussion:
- ARSI PR wars: Nubeqa (Bayer) vs Erleada (J & J) lawsuit https://connect.mayoclinic.org/discussion/arsi-pr-wars/
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3 Reactions@xahnegrey40
I have heard this type of comment from dozens of people. Over at the ancan.org weekly advanced prostate cancer meetings There are a couple of dozen people at least (Almost 50 show up at each meeting) Who have switched to Nubeqa And are really pleased with it and many of them are using it as the only drug they’re on. I’ve also recommended it on the other three online groups I meet with and many people there have switched and have been really pleased with it, And start recommending it to other people.
The statistic about only one percent or less of people on Enzalutamide Having fatigue seems to be laughable. I’ve heard so many cases of fatigue from that drug. Not nearly as many people are on Apalutamide So a comparison is hard to draw, for me.
I am just a little dubious of the testing results versus real world experience of what I’ve seen and heard. I will not be able to comment on the reduction in brain fog for people who are just on Darolutamide, Because it really has not been discussed at all in any of the forums I’ve been on. I think that is something that is hard to judge in the older population.
Yesterday I was sitting down with a neighbor/friend For an hour, discussing a lot of different things. He’s about six months older than I am. We both kept blanking out on the names of things. He was just as bad as I am, And I thought my brain fog was the main issue. Maybe being 78 is part of the problem. I did have a lot more names on the tip of my tongue, that I brought out in our discussions, So the brain fog hasn’t gotten me down completely.
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3 Reactions