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In case you have not already seen this, here is a link to the FDA website with lots of information on generic drug equivalency. Sometimes pharmacies will carry more than one generic drug manufacturer for a specific drug, so you can always ask for a different manufacturer if you’re not happy with the one they are giving you. That has worked for me in the past. I have instructed them that I don’t want any generic drugs from company XYZ and they will honor that.
https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers#:~:text=Any%20generic%20medicine%20must%20perform,(with%20certain%20limited%20exceptions).Yes, Rick has it right — the way the original darolutamide trial was designed, it limited the approval to just nmCRPC which we now know to be an erroneous disease stage since it is highly likely that if a patient is CRPC, they are probably already micrometastatic. And PSMA-PET scans are proving this to be true. If someone is struggling with cognitive issues on enza or apa and their medonc refuses to switch them to daro, we suggest they find another medonc, assuming their insurance allows for that.
I’m not a statistician, but the difference between 1.1% (daro) and 1.8% (enza) is actually quite large — the HR for cognitive disorder for enza compared to daro would be 1.6 — that’s huge.
Those stats for the DEAR study were misquoted. The actual numbers Morgans reported were for cognitive disorder were:
Daro – 1.1%
Enza – 1.8%
Apa – 1.6%
In this DEAR study, the median age of participants was 80. And 27% were over 85! It seems to me that age alone could account for cognitive disorder, leveling things out among the three lutamides.
Also, in this Antonarakis pub: (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6816030/) he reports: “darolutamide has negligible blood-brain barrier penetration… of about 2% compared to 25% for enzalutamide”
That’s quite a difference. Finally, in the DEAR study, daro had significantly fewer patients discontinuing therapy compared to enza and apa, and the most likely reason would be less cognitive disorder with daro because progression to mCRPC was lowest in patients taking daro. Ideally, they would have asked the patients why they discontinued therapy, so that’s quite a weakness of this “retrospective chart review.”