Xtandi beneficial in reducing radiogr... - Advanced Prostate...

Advanced Prostate Cancer
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Xtandi beneficial in reducing radiographic progression-free survival (rPFS) in men with metastatic hormone-sensitive PC

Tall_Allen
Tall_Allen

Not FDA-approved yet. The FDA has recently accepted rPFS as a surrogate endpoint for overall survival. It remains to be seen if they will accept it for this indication. No data yet:

investors.pfizer.com/invest...

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Tall_Allen
Tall_Allen
in reply to Hidden

If you have had any PSA progression while taking a GnRH agonist (e.g., lupron) and you've been previously diagnosed with metastases, I think most insurance would approve Xtandi or Zytiga for you.

Yeah, just saw this on my news feed. I know that using PFS as a surrogate for OS is controversial (in any case I know it is in lung cancer). I really don't understand why, unless it turns out improved PFS does not lead to improved overall survival.

Yes, that's why. It's not at all clear that delaying the detection of new metastases prolongs survival. The FDA has just issued new guidance on surrogate endpoints:

fda.gov/downloads/drugs/Gui...

They suggest that drug companies consult with them before designing clinical trials. They approved Erleada and Xtandi for non-metastatic CRPC based on rPFS, but that's a different situation.

Thanks!

COG1
COG1
in reply to Tall_Allen

The trial my husband is on is using radiographic progression free survival as an endpoint. this is interesting.

What am I missing? I thought xtandi was already approved for use with androgen deprivation therapy?

Tall_Allen
Tall_Allen
in reply to cesanon

It's approved for castration-resistant PC (both metastatic and non-metastatic) but not for metastatic hormone-sensitive PC.

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