All right, welcome. Today is April 12th, 2024, and the U.S. Food and Drug Administration is hearing a proposal to use minimal residual disease as a primary endpoint of studies for accelerated approval to give drugs in newly diagnosed multiple myeloma and accelerated approval based on MRD negativity. It's a nine or 12 months, and subsequently follow them for PFS and OS.

And they've been discussing this at great length.

It appears from the discussants and the FDA's briefing document

that everybody is on board.

Well, not everybody.

So here are some reasons why MRD testing,

accelerated approval would be a disastrous policy decision. I'm going to give you my case,

and I'm going to present an abbreviate version of these remarks at the FDA hearing within the hour.

All right. Use of MRD testing and endpoint multimaloma clinical trials.

I think the FDA has lost sight of the entire goal of this operation. The goal of FDA drug approval

is to grant marketing authorization to patients with newly diagnosed myeloma that results in a

longer life or a better life, living longer or living better? Using MRD testing as an end point

for accelerated approval would be an error for five important reasons. Okay, let's go through the

reasons and at least

the first two are interlinked. Number one, in order to create accelerated approval endpoints,

you have to evoke an unmet medical need. There is no unmet medical need for newly diagnosed

multiple myeloma. It does not qualify for unmet medical need by any reasonable definition.

Number one, the four-year overall survival in the most recent study, Perseus, is 90% OS for Darrow-V-R-D and 88 for VRD.

The median survival was 8 to 10 years prior to this study.

For a patient enrolling tomorrow in a clinical trial where MRD as an endpoint will be applicable,

that median survival for such a patient may be 15 years.

How can we say it's an unmet medical need when the median overall survival is 15 years

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