Biotech Values

[gofishmarko]

On Vectibix , PCYC , DNDN and the FDA

The FDA deserves be on the hot seat right now as other companies ask for a second look at their data , since the lack of logic ( and integrity ? ) in the accelerated approval process is now too obvious to ignore.

This is what they said about Vectibix :

"Although the pivotal trial failed to show evidence of an impact on overall survival, FDA Division of Biologic Oncology Products Director Patricia Keegan noted in her recommendation to approve the biologic that "improvements in [progression-free survival] are generally accompanied by improvement in overall survival."

"Generally" , AKA : "sometimes". Not this time , though , in the case of Vectibix.

The purpose of Accelerated Approval is to get drugs on the market that are very likely to improve survival based on "surrogate data" , with the understanding that they will get full approval only if they subsequently demonstrate the survival benefit.

Now , suppose you had a bunch of NDAs or BLAs to review , with data packages similar to either :

1) The Vectibix data , on PFS.

or

2) The DNDN data , on actual survival.


Which group would have a better chance of eventually demonstrating improved survival ? I'd bet my money on the group "2" drugs , and I'd call the person crazy that said ONLY the group "1" drugs are eligible for Accelerated Approval , the situation that now pertains at the FDA.

Yeah , I hope there's some sweaty brows at the FDA right now as they try to decide what to do with DNDN. Maybe they'll decide that the best decision will be the one that makes the most sense.

In other words , time to start doing things differently.