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