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/
- Forums
- ASX - By Stock
- success for avastin in europe
There's debate whether using PFS as a surrogate marker for OS is...
-
- There are more pages in this discussion • 5 more messages in this thread...
You’re viewing a single post only. To view the entire thread just sign in or Join Now (FREE)
Featured News
Add IMM (ASX) to my watchlist
(20min delay)
|
|||||
Last
40.5¢ |
Change
0.005(1.25%) |
Mkt cap ! $588.3M |
Open | High | Low | Value | Volume |
40.0¢ | 40.5¢ | 39.8¢ | $2.431M | 6.045M |
Buyers (Bids)
No. | Vol. | Price($) |
---|---|---|
1 | 6880 | 40.0¢ |
Sellers (Offers)
Price($) | Vol. | No. |
---|---|---|
40.5¢ | 85353 | 3 |
View Market Depth
No. | Vol. | Price($) |
---|---|---|
1 | 6880 | 0.400 |
3 | 153861 | 0.395 |
5 | 142266 | 0.390 |
5 | 73412 | 0.385 |
11 | 201885 | 0.380 |
Price($) | Vol. | No. |
---|---|---|
0.405 | 85353 | 3 |
0.410 | 269251 | 11 |
0.415 | 239943 | 10 |
0.420 | 492300 | 8 |
0.425 | 50700 | 3 |
Last trade - 16.10pm 12/09/2024 (20 minute delay) ? |
Featured News
IMM (ASX) Chart |