Welcome back to a breaking edition of plenary session.

This is being recorded on Christmas Eve, and I hope to put it out on Christmas Eve.

I'm joined by Dr. Mani Mouyuddin, an assistant professor at the Huntsman Institute in Utah.

I'm joined by Raj Chuck Robodi, who is an assistant professor at Columbia University,

and I'm joined by Aaron Goodman, Associate Professor at the University of California, San Diego,

and we're here to talk about two concerning safety signals with the CART products that have

been released about a couple weeks ago and then just in the last couple of days.

Moni, take it away.

So what are we hearing about CART products in myeloma?

What's the safety signal going on here?

All right.

So there are two FDA-approved products, CART products in myeloma, what's the safety signal going on here? All right. So there are two FDA approved products, carti products, and myeloma.

There's idicell and then there's SILTA cell.

So what we just heard from the FDA relates to SILTA cell.

And this was in its original trial that led to accelerated approval, which was the CARTitude

one study in which 97 patients got Silta cell.

And we just found out that amongst those 97 patients, 10 patients,

developed myeloid malignancies.

So that's very concerning, a 10% rate of myeloid malignancies amongst 97 people who got Silta cell.

Now, this is in the backdrop of some news

that came a few weeks ago,

where the FDA had an announcement

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