for advocates: Accelerated approval overview by FDA - slides

[Guest guest]

Accelerated Approval (AA) for Oncology Drug Products:

An Update and Regulatory Overview

G. Kluetz, MD Medical Officer

Office of Oncology Drug Products

http://bit.ly/gpr2as

Trial Design - Initial AA

.. Trial design for initial accelerated approval (AA)

- 20/49 were randomized comparative

- 29/49 were single arm

.. Surrogate endpoints used:

- Response Rate and Duration = 36

- Time to Event = 10 (PFS, DFS and TTP)

- Other = 3

Fleming: " Given that there seems to be a sense of urgency in

completing the trial upon which accelerated approval is granted, is it fair

to assume that we would have the same sense of urgency for the confirmation

of benefit?

.... In the first case we are in danger of keeping dying patients away from

potentially effective therapies, however there is an equal danger that we

are exposing patients to the toxicity of therapy without certainty of

benefit.

In both cases it is incumbent upon those in drug development to decrease

these time periods. "

- Fleming, 2003 ODAC on Accelerated Approval

All the best,

~ Karl

[Guest guest]

Hello, my CLL friends

For those who would like to grease the Drug approval system, I take

exception to these statements by Fleming and IMO illustrate the problem

with many in power at the FDA and in charge of the process itself.

The statement " however there is an equal danger that we are exposing

patients to the toxicity ect. ect " . is flawed. The word " equal " is obviously

inappropriate. When a patient is at the end of their life span from lethal

disease, the only rational progression is death. That IS NOT EQUAL to the

fact that a new technology has the potential to bring a cure or improvement in

the disease condition. Certainly, a new technology may be the straw that

breaks the camels back when someone is already close to death, but if they

are truly well informed, why not let that be the patient's choice? Where is

the harm? And let's be honest. It is not equal!!

Still hoping for a better more efficient system. I believe we can do it.

Leo