Welcome to Plenary Session.

I'm Vinay Prasad. I'm an associate professor with University of California, San Francisco.

I'm a practicing he-mong doctor, and my interests are medicine, oncology, and health policy.

And that's what you're going to get on Plenary Session.

This is season four, hashtag zero COVID.

It's zero COVID because we're not going to talk about COVID.

We're back, oncology, medicine, health policy.

We've got a lot in store for you.

But first, a plug.

If you like this podcast, leave us a rating or write us a review. It helps new listeners find the show. You can follow us on Twitter at Plenary underscore Session. You can email us at plenary session podcast at gmail.com. Give us your suggestions on what we should be covering. And we got a new YouTube channel, Vinay Prasad, MDMPH. Follow us on YouTube. I'm putting up a 10-part series on reading and interpreting cancer clinical trials.

You'll want to watch it there.

And if you really love this show, you can back us on patreon.com.

Patreon backers get access to slides for lectures I give on plenary session.

And with that, let's start the show.

I'm here to talk about our new paper on the FDA's ODAC in late April that appears now in JAM Oncology. Let me show you to you, because picture's

worth a thousand words. Here it is. The Oncology Drug Advisory Committee votes of April 2020,

implications for the fate of accelerated approval. It's by myself, Logan Powell, Mark Lithgow.

It should be something very interesting for people interested in regulatory policy. And let me walk

you through what it is and what it's about. First, I think you need to know something about

accelerated approval. The U.S. Food and Drug Administration has two fundamental types of approval.

They have a regular or traditional marketing authorization,

which means that they are largely satisfied with efficacy. They believe that the drug product has

...