There's debate whether using PFS as a surrogate marker for OS is meaningful.
But if, as seen with Avastin, approval is gained on PFS alone, then perhaps the CAN-003 study may not need to wait for the secondary endpoints for approval.
My understanding was as below:
"The FDA has made it very clear that they will not approve drugs for ovarian cancer based upon PFS alone, and they are essentially demanding a difference in overall survival,”
- http://www.onclive.com/publications/oncology-live/2012/february-2012/Benefits-of-Bevacizumab-in-Ovarian-Cancer-Clarified/1
Yet, after 2 studies with no significant OS benefit and a 3rd with no OS data available, it's been approved.
- http://news.cancerconnect.com/avastin-delays-progression-of-ovarian-cancer-but-may-not-improve-overall-survival/
There's debate whether using PFS as a surrogate marker for OS is...
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