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New Drug Approval for Non Metastatic Castrate Resistant PC

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Posted 2/15/2018 1:52 PM (GMT 0)
I'm no expert in advanced PC but this looks like it could be a big deal
/www.fiercepharma.com/marketing/fda-gives-j-j-s-erleada-a-quick-push-over-finish-line-first-ever-non-metastatic-prostate

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It’s data that was released in detail just last week at ASCO’s Genitourinary Cancers Symposium, the same meeting where similar Xtandi data made its debut. In a trial called Spartan, Erleada delivered 40.5 metastasis-free months, a 24.3-month improvement over current therapy."
Posted 2/15/2018 6:04 PM (GMT 0)
Prat:
Yeah, I read about this on another site. Typical nasty SE, as expected.
Here is part of what I just sent to Dr. Lam:

>>>>>>>>>>>>>>>
Hi Dr. Lam:


My next PSA will be in about 5 weeks.
If it eventually goes up enough, I plan to get back on Lupron/Casodex.
If that should fail, we have:
zytiga, xtandi.
But I just read this:

https://www.cancerabcs.org/new-advanced-metastatic-prostate-cancer-blog/2018/2/15/a-new-drug-approval-erleada-apalutamide-for-non-metastatic-castration-resistant-prostate-cancer

Where does this drug fit in?

Mel


>>>>>>>>>>>>>>>>>>>
Posted 2/15/2018 6:19 PM (GMT 0)
Mel, good to see you here, hope you are doing well.

It will be interesting to see what Kwon's,response will be.
Posted 2/15/2018 7:38 PM (GMT 0)
Mel-

Good to hear from you! I hope your rehab is coming along well.

It doesn't apply to you at all. It only applies to men who are non-metastatic (M0) and castration resistant (you aren't castration resistant), a pretty rare combination of circumstances (and I suspect, virtually non-existent if they had used one of the advanced PET scans for detection of metastases.). Erleada, as they call it, seems to be even more expensive than Zytiga, and has some significant side effects. It is unknown if it has any net survival benefit for this subgroup.
Posted 2/15/2018 10:34 PM (GMT 0)
Hi TA:
PC is way down on the list as I am struggling with other issues.
However, re-read my post.
I would be CR IF I got back on HT and it failed. That was the circumstance I delineated.
Also, I did read that lymph node involvement was okay (to use the new drug).
I guess they mean distant/bony mets as being exclusionary.

Mel
Posted 2/16/2018 1:34 AM (GMT 0)
Gotcha - you're playing "what if..."

While Erleada is a new drug, Zytiga will probably be approved for the same indication very soon. Between the two, I'd go with Zytiga because there is a long history of known SEs with it. The SE profile of Erleada is pretty serious, so if there's no known advantage of Erleada over Zytiga, why risk it?
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