The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, with a two-day, back-to-back marathon meeting, signaling a return to business at FDA after significant upheaval at the agency.
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In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter and Jacquelyn Cobb, associate editor, talk about Jacquelyn’s coverage of the ODAC “marathon.”
“We’ve definitely talked about how, maybe two or three podcasts ago, the idea that what we would give to just cover an ODAC, and then the universe was like, ‘Here’s four,’” Jacquelyn said.
“What was really interesting is that they were able to handle all that, and we have no idea how many people really are remaining at FDA in parts of FDA oncology,” Paul said. “It didn’t get too badly clobbered, although from what I understand, the middle level, kind of like people who are between the OCE director and the medical reviewers, they’re sort of all gone. They’ve all moved on or mostly gone, so it’s a different game, but it also tells you how important it is to have this agency and to have this function, to have the vision.
“I don’t know where we are in all of this, but it’s nice to know that as of last week, things functioned.”
Stories mentioned in this podcast include:
- ODAC marathon: Committee charges through a pileup of clinical questions in a two-day, four-application session
- Guest editorial by Peter Nelson: Biden’s diagnosis is unfortunate but—statistically—not surprising. Of the 384 men serving in Congress, 48 are likely to be diagnosed with prostate cancer in their lifetime.
- Guest editorial by Eric Lefkofsky and Norman E. Sharpless: Unlocking the future of precision medicine: The untapped power of RNA
- A new AI tool enables speedy use of ASCO guidelines, eliminating typical errors
- PAMN becomes CMCA—the Cancer Marketing & Communications Association—as its size and scope expand
- The faces of RIF: Staff members of NCI’s dissolved communications team gather for a farewell group photo
- FDA Commissioner Makary holds roundtable discussion on harms of talc
- Prasad’s stricter FDA policy for COVID-19 vaccines could limit future access
This episode was transcribed using transcription services. It has been reviewed by our editorial staff, but the transcript may be imperfect.
The following is a transcript of this week’s In the Headlines, a weekly series on The Cancer Letter podcast:
Jacquelyn Cobb: This week on the Cancer Letter Podcast.
Paul Goldberg: We have no idea how many people really are remaining at FDA. In parts of FDA oncology didn’t get too badly clobbered, although from what I understand, the middle level, kind of like people who are between the OCE director and the medical reviewers, they’re sort of all gone, moved on, or mostly gone, so it’s a different game, but it also tells you how important it is to have this agency and to have this function, to have the vision.
I don’t know where we are in all of this, but it’s nice to know that, as of last week, things functioned.
You are listening to the Cancer Letter Podcast. The Cancer Letter is a weekly independent magazine, covering oncology since 1973. I’m your host, Paul Goldberg, editor and publisher of The Cancer Letter,
Jacquelyn Cobb: And I’m your host, Jacquelyn Cobb, associate editor of The Cancer Letter. We’ll be bringing you the latest stories, groundbreaking research, and critical conversations shaping oncology.
Paul Goldberg: So, let’s get going.
Jacquelyn Cobb: Good morning, Paul. How’s it going?
Paul Goldberg: Oh, it’s going great. How are you, Jacqueline? How was your weekend? You’re in Maine, and I understand your car broke down in Maine?
Jacquelyn Cobb: Yeah, it didn’t fully break down, and now I’m back in Massachusetts. It was a whole thing. But yeah, we tried to get an oil change, and they were like, “You need to get this to a mechanic ASAP,” so we just decided.
Paul Goldberg: So, you made it from Maine to Massachusetts without a mechanic?
Jacquelyn Cobb: Yeah. Well, we didn’t know about it and we actually, we went to New Hampshire too. We went to the White Mountains. It was fine. Apparently, she’s been leaking for a while, so hopefully it’ll be okay, but we got to get her to the mechanic ASAP.
Paul Goldberg: You’re not by the side of the road with a jack and…
Jacquelyn Cobb: Yes, that has happened once with this car, but thankfully not this time. She’s gotten us far.
Paul Goldberg: Do you have spares in your car?
Jacquelyn Cobb: I don’t think so. We don’t even have a spare tire anymore, because my car is so old that it’s-
Paul Goldberg: Used.
Jacquelyn Cobb: No, I didn’t even use it. It got flat before we even put it on the car. That’s how old it is, so it’s fine. I don’t want to worry our listeners with my driving habits, and my parents listen to this, so they’re going to be like, “What are you doing?”
Paul Goldberg: Your parents? You allow your parents to listen to this?
Jacquelyn Cobb: Listen, I don’t control them. They have access to YouTube, so let me walk through the headlines to divert from that. Hi, mom and dad.
I am going to start in the middle this week, because we’re going to jump into the cover story as our main sort of talking point, so we had a guest editorial by Peter Nelson about former President Joe Biden’s prostate cancer diagnosis, as well as a guest editorial by Eric Lefkofsky and Ned Sharpless about the untapped power of RNA.
Claire wrote a story about a new AI tool that enables speedy use of ASCO clinical guidelines, and I wrote a story about the Public Affairs and Marketing network rebranding to become the Cancer Marketing and Communications Association.
It’s also worth mentioning, even though it’s not one of our typical story order stories, that the cancer policy section, which was headed up by Claire this week while I was elbows deep in covering ODAC, was also a monumental effort, and there’s a lot to check out.
FDA Commissioner Marty Makary held a roundtable on talc being a carcinogen, and she also covered new FDA COVID vaccine policies.
Finally, I’ll talk about our cover story, which was a monster. The Oncologic Drugs Advisory Committee held its first session since President Trump’s inauguration, and during two, back-to-back, all-day meetings, and that was Tuesday and Wednesday, so we had basically Thursday to write it, four applications were brought before the committee.
And Paul, I don’t know if you want to say something before I dive into just what those were and give, as brief as I can, overview of what happened, or if you want me to just—
Paul Goldberg: Yeah. It’s actually an amazing story. I actually got very tired editing it, and I didn’t even write it, so I don’t know how you pulled it off. I mean, you definitely, it was a team effort, but you ran the team, so my hat is off. In fact, I should put it on before I take it off. My hat is on, and now my hat is off to you for having done this, because that’s no small thing.
The story is just interesting to me, because FDA does still, still is a key word and I hope forever, has the capacity to manage something like this, the intellectual power, the regulatory power to handle so many questions, back to back, four of them. Usually ODAC is one, two, rarely three, almost never four, these days. I mean, it’s been different things at different times, but four applications, it has been years. I’m sure it’s happened. It’s an old committee.
Jacquelyn Cobb: Yeah, yeah. Definitely in recent memory, and it was kind of weird. They had sort of an impromptu visit from FDA Commissioner, Marty Makary, and CBER director, Vinay Prasad, and they just stopped by to say hello. Makary had some pretty fun, silly jokes about using the trial names to make some puns and things like that, but have you ever seen a FDA Commissioner just show up at an ODAC call? I’ve never seen it.
Paul Goldberg: Have I? No, I have never seen an FDA Commissioner just pop in and say we were in the neighborhood and thought would stop by and both FDA Commissioner and CBER director, the new one, Vinay Prasad, which is another part of the story. But yeah, and there’s nothing wrong with that. That’s just fine. I guess one disadvantage might be that it might look like there somebody is trying to sway the committee, but this is not a committee that’s easily swayed, so I’m not as worried about that at all.
In this case, Marty Makary did mention national interest in China and so forth, and this was just, in fact, a regulatory question involved conduct of clinical trials offshore, and specifically in Asia, so I didn’t want to read too much into it. It was nice. It was kind of always nice to see a change of pace, is always a good thing. Actually, Jacquelyn, what might be good, is we should just go through those four applications and why they’re there and the questions asked.
Jacquelyn Cobb: Totally. You read my mind, so I’m going to say number one, two, three, and four, just for ease of listening. Like I said, I try to make these as brief as possible, so please excuse a little bit of rambling.
So, number one, ODAC, and this is the one that Paul was already talking about, ODAAC recommended against the approval of glofitamab injection for the treatment of relapsed refractory diffused B-cell lymphoma submitted by Genentech Inc. The application was brought before ODAAC because of disparate clinical trial results between participants enrolled in Asia, compared to those enrolled in non-Asian regions, including Europe, the US, and Australia, calling into question whether the trial results were generalizable to a US population, so that’s what Paul was talking about and what Makary sort of mentioned when he stopped by to say hello, in terms of national interest and that type of thing.
Number two, ODAC recommended the approval of Darzalex Faspro for the treatment of high-risk smoldering multiple myeloma submitted by Janssen Biotech Inc. The application was brought before ODAC for two reasons. I thought this one was really interesting. FDA was unsure of the clinical meaning of the trial’s efficacy endpoints in smoldering myeloma because it’s a precursor condition that’s not classified as an active cancer. So that was just a pretty interesting sort of regulatory question, and the second reason was that the criteria used in the trial to actually diagnose patients with high-risk smoldering multiple myeloma, excuse me, the indication in which the applicant is seeking approval is now outdated. So, it was sort of like, how do we even test these people? We don’t know who these people are.
Number three, ODAC was split ultimately on the approval of mitomycin for the treatment of low-grade intermediate risk and non-muscle invasive bladder cancer submitted by UroGen Pharma Inc. The application was brought before ODAC, because UroGen, against FDA advice, submitted a single arm trial to support its application and an indication where a randomized control trial was technically feasible.
It was not performed that way though. Well, actually, to be fair, they did start a randomized clinical trial, but then they stopped it due to “business reasons.”
Number four, ODAC recommended against the approval of Talzenna for the treatment of metastatic castration resistant prostate cancer submitted by Pfizer. This was easily the most decisive vote. It was the only unanimous one, and it was brought before ODAC, or the application was brought before ODAC because Pfizer tested Talzenna, which is an already approved biomarker, directed PARP therapy, in a biomarker agnostic population without powering the study to test the clinical impact of the drug on the biomarker negative patients. So basically, they just didn’t make sure that it would work in biomarker negative patients. Statistically, they just looked at it in all comers, so that was really interesting. I mean, they’re all interesting.
I love ODACs, but that’s the briefest I could do in terms of explaining what happened. Yeah.
Paul Goldberg: No. That was actually, your reading has gotten so much faster since we started the podcast. You could probably read an ODAC application faster than AI, which probably stage the competition Jacquelyn versus AI, and you’ll win, hands down.
Jacquelyn Cobb: Well, I’m on my second coffee, and I’m already a pretty fast talker, so that’s probably part of the reason.
Paul Goldberg: Very helpful. Very helpful. So yeah, what was really interesting is that they were able to handle all that, and we have no idea how many people really are remaining at FDA in parts of FDA oncology. It didn’t get too badly clobbered, although from what I understand, the middle level, kind of like people who are between the OCE director and the medical reviewers, they’re sort of all gone. They’ve all moved on or mostly gone, so it’s a different game, but it also tells you how important it is to have this agency and to have this function, to have the vision. I don’t know where we are in all of this, but it’s nice to know that as of last week, things functioned.
Jacquelyn Cobb: Yeah, yeah. Forgive me if I’m wrong, I know we talked about this a little bit off camera, so I’m not sure if I’m repeating here, but the idea that this is the first ODAAC, the first convening of the ODAAC since Trump’s inauguration. After immediately following his inauguration, there was sort of this communication silence, and then they slowly started putting out approvals and guidances, slowly increasing their communications, and now it seems like it’s back to business as usual.
I know that Makary started a new podcast as well. It seems like they’re full-blown, back to communications. Is that accurate, Paul? Would that be fair?
Paul Goldberg: It seems that way, yeah. It’s basically, the blackout post-election, plus the time it takes to announce a meeting, and maybe a little bit more on top of that, so that’s what we’re in at the end of May or mid-May, in that case last week, when things could catch up, which is great that they were able to catch up.
Jacquelyn Cobb: Yeah, yeah. I mean, imagine if they weren’t able to have this. It was very fruitful conversations, very important insight from the leaders in oncology. I’m personally grateful that I get to see inside some of these decisions, the logic behind some of these decisions for approval or not approval, so definitely.
Paul Goldberg: Well, the committee is fabulous. The committee is always fabulous. It’s always nice to hear these discussions. I mean, one of the reasons this job is such a privilege and so fun, even when the times aren’t great as they are to be a journalist, is that in oncology, you get to watch erudite discussion, clinical issues and scientific issues of all sorts as kind of a spectator sport. It’s really incredible to watch. I don’t know if you share that.
Jacquelyn Cobb: Oh my God, yes. I think it’s funny. We’ve definitely talked about how, maybe two or three podcasts ago, the idea that what we would give to just cover an ODAC, and then the universe was like, “Here’s four.”
Paul Goldberg: “Here’s four,” but we knew it was coming. Come on. You’ve got to give us more credit than that.
Jacquelyn Cobb: Yes. Of course, of course. But still, it’s funny that we definitely wanted this, and then it definitely came out with full force.
Paul Goldberg: It was definitely, I got tired just editing it.
Jacquelyn Cobb: Yeah, yeah. It was a lot.
Paul Goldberg: Can’t imagine how difficult it’s for you.
Jacquelyn Cobb: Yes, and I wrote another story on top of that last week, so it was definitely a crazy week, for sure.
Paul Goldberg: In your spare time.
Jacquelyn Cobb: In my spare time. I didn’t really have much spare time last week. It was pretty much the cancer letter, but like I said, very exciting to cover ODAC and, like you’re saying, it is truly enjoyable to watch as a spectator sport. It’s fascinating. I think it is a privilege, really, to see the discussion and see how it’s worked out, because none of these, except for one, was unanimous. All of them were a discussion, so I love it.
Paul Goldberg: Well, it’s also interesting when ODAC splits, and it’s also interesting how having the top experts, as they did in the Jensen application and top experts in the field, basically present a case that clearly carries weight with the committee.
Jacquelyn Cobb: Yes.
Paul Goldberg: So, there is this kind of a dialogue that you’re starting to see, and it doesn’t always help. They also had the data, or the argument at least, that worked.
Jacquelyn Cobb: Yeah.
Paul Goldberg: Yeah. No, it was a very interesting week, in terms of ODAC was kind of the star of the week, which also is great, because so much of the time was spent on just a cut here, a cut there, people fired here, people fired there. There was actually another bit that was very interesting, and it was just a brief. Well, it was a lead brief in cancer policy, and that was the communications people from NCI kind of gathering for a party at Peter Garrett’s house, and there was this photograph, and that’s kind of the faces of riff. I think that just being there and having that photo is so important, because we keep forgetting. Well, we don’t forget. We all know it’s happening. We hear about it every hour, but nobody should forget.
Jacquelyn Cobb: Yeah, yeah. And it was nice to see them all together. It’s nice to see them smiling. I know their life isn’t easy right now. They’re going through a lot, but it seems like there’s a lot of camaraderie between them and support, and sharing this together is one very, very, very small silver lining in all of this, I guess.
Paul Goldberg: Yeah, yeah. Well, as Kim Rathmell has said time and time again, her columns here in the cancer letter, we all have to be taking care of each other at this point, at this time, and making sure everybody is okay. It’s a tall order to try to figure out whether everybody is okay, because not everybody is going to be okay, but it’s a very sad time to be a journalist.
Jacquelyn Cobb: Yeah. All right. Well, I think we covered everything that was on our list. Is there anything that I’m forgetting, Paul?
Paul Goldberg: I think we covered a lot. I think we covered a lot. ODAC is the star of the week. Again, my hat’s off to you, and my hat is off to the committee members, whose deliberations were the same as always, and to the people who processed those applications and prepared those reports and arguments and slides, and it’s nice to see business as usual.
Jacquelyn Cobb: Absolutely. All right. Well, thank you, Paul, and I’ll see you next week. Thank you for joining us on The Cancer Letter Podcast, where we explore the stories shaping the future of oncology. For more in-depth reporting and analysis, visit us at cancerletter.com. With over 200 site license subscriptions, you may already have access through your workplace. If you found this episode valuable, don’t forget to subscribe, rate, and share. Together we’ll keep the conversation going.
Paul Goldberg: Until next time, stay informed, stay engaged, and thank you for listening.
