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

Advanced Prostate Cancer

20,783 members25,890 posts

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

Tall_Allen profile image
7 Replies

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...

Written by
Tall_Allen profile image
Tall_Allen
To view profiles and participate in discussions please or .
Read more about...
7 Replies
dentaltwin profile image
dentaltwin

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.

Tall_Allen profile image
Tall_Allen in reply to dentaltwin

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.

dentaltwin profile image
dentaltwin in reply to Tall_Allen

Thanks!

COG1 profile image
COG1 in reply to Tall_Allen

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

Tall_Allen profile image
Tall_Allen

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.

cesanon profile image
cesanon

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

Tall_Allen profile image
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.

You may also like...

Pluvicto increases radiographic progression-free survival (rPFS) before chemo

The FDA may approve the new indication based on rPFS (i.e., they may not require full overall...

Enzalutamide Extends Radiographic PFS in Metastatic Hormone-Sensitive Prostate Cancer

e-highlights-gugi-2019/interim-analysis-of-the-arches-trial/

FDA Approves Darolutamide Plus Docetaxel for Metastatic Hormone-Sensitive Prostate Cancer

onclive.com/view/fda-and-ema-approval-sought-for-darolutamide-plus-docetaxel-in-metastatic-hormone-s

Short-term androgen annihilation in non-metastatic recurrent men delays progression

radiation, and no metastases on conventional imaging yet, there may be an advantage to adding...

Two new advanced hormonal agents (apalutamide and enzalutamide) increase survival in metastatic hormone sensitive prostate cancer (mHSPC)

previously approved drugs - Erleada and Xtandi. I don't have all the details yet on Xtandi, but it...