Denied

Today the FDA denied Roche's application for fastrack approval of TDM-1 based on what seems to be a technicality. It was generally thought, given the convincing results of Phase II trials conducted in heavily pre-treated woman, that the drug would be approved for commercial use in the first months of 2011. It has now been delayed until at least mid-2012.

You can read the full story here.

This is devestating news for women with HER2 positive breast cancer. This development does not affect me directly because I am guaranteed, through my participation on the clinical trial, to have uninterrupted access to TDM-1 as long as it continues to work for me. But indirectly, I am sad, mad and frustrated for the thousands of women who did not qualify for clinical trial (the requirements are very specific) and will run out of time before 2012 arrives. I know I would have, had I not been accepted into the trial.

TDM-1 (not at all discounting divine intervention) has saved my life, plain and simple. It is a travesty that women who have no other options cannot receive this drug.

I certainly understand the importance of properly conducted clinical trials. I definitely believe that drugs, before they are released to the public, need to be thoroughly evaluated. But why isn't there a provision for the compassionate use of drugs which, though not completely evaluated, show such promise that they just might turn the tables for someone who has no other option and is surely going to die without at least a try? It seems to be only humane.

In the meantime, keep at it, Roche--and I'll keep providing you the data you need to help bring this baby to market.