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ARSI PR wars: Nubeqa (Bayer) vs Erleada (J & J) lawsuit
Prostate Cancer | Last Active: 1 day ago | Replies (36)Comment receiving replies
I 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. '
Replies to "I suspected this: seems Nubeqa has been poaching a large number of PC patients who didn..."
For 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
my 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)
@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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Yes. 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.