Monday, April 11, 2011

Accelerated Approvals are Too Fast, Except When They're Too Slow

A great article in Medscape reports on two unrelated articles on the FDA’s process for granting (and following up on) Accelerated Approvals of oncology drugs.

First, a very solid review of all oncology drugs approved through the accelerated process since 1992 is in the latest journal of the National Cancer Institute. The review, written by FDA personnel, is in general concerned with the slow pace of confirmatory Phase 3 trials – over a third (18 of 47) have not yet been completed, and even the ones that have completed have taken considerable time. The authors consider process changes and fines as viable means for the FDA to encourage timely completion.

Second, over at the New England Journal of Medicine, Dr Bruce Chabner has a perspective piece that looks at the flip side: he argues that some compounds should be considered even earlier for accelerated approval, using the example of Plexxikon’s much-heralded PLX4032, which showed an amazing 80% response rate in Metastatic Melanoma (albeit in a very small sample of 38 patients).

I would argue that we are just now starting to get enough experience to have a very good conversation about accelerated approval and how to improve it -- still, less than 50 data points (47 approved indications) means that we need to remind ourselves that we're still mostly in the land of anecdote. However, it may be time to ask: how much does delay truly cost us in terms of our overall health? What is the cost of delayed approval (how many patients may potentially suffer from lack of access), and correspondingly what is the cost of premature approval and/or delayed confirmation (how many patients are exposed to ineffective and toxic treatments)?

The good news, to me, is that we're finally starting to collect enough information to make a rational estimate of these questions.

1 comment:

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