2-Min Drill: ASH 2023 Data in Multiple Myeloma Slated for FDA Approval
Joshua Richter, MD, of Mount Sinai, and other hematologic cancer experts join CancerNetwork following the 2023 ASH Annual Meeting & Exposition to discuss data from the conference that are most likely to lead to an FDA approval.
Joshua Richter, MD, of Mount Sinai, and other hematologic cancer experts join CancerNetwork following the 2023 ASH Annual Meeting & Exposition to discuss data from the conference that are most likely to lead to an FDA approval.
Richter: Next topic, 1 minute each. We just heard the most practice-changing [data]. But before all of that, what trial is going to lead to the next FDA approval in the soonest time following ASH, or even from any data this year? What's going to be on the soon horizon for approval? Let's see. I think Dr Usmani, I think it's your turn to lead us off.
Usmani: All right, the 2 big phase 3 trials that read out, KarMMa-3 and CARTITUDE-4 for this year, were the major highlight. All of us are holding our breaths to see if those FDA approvals will come through. There were several highlighted abstracts, including the KarMMa-3 update from from Dr Paula Rodríguez Otero, on Monday night at ASH 2023. Those will be the most impactful abstracts and will lead to the quickest FDA approvals in the earlier-line setting.
Richter: Straightforward, wonderful answer, although KarMMa-3 didn't quite get it this year like we thought it might, but I think the PDUFA date for CARTITUDE-4 is around April 6. So a straightforward answer—I'll give you a 10 points. Dr. Matous, sir, your thoughts?
Matous: I wanted to go first. obviously I think it's cilta-cel CARTITUDE-4; it just needs to be and you guys are probably doing the same thing I'm doing in clinic, which is seeing people who are in early first relapse or early second relapse and you're saying, "I think I have a trial for you." But if not, this approval has got to be right around the corner, my goodness. The New England Journal of Medicine paper was July 27. Usually you know how it goes, right? Meeting, New England Journal of Medicine paper, and FDA approval. I'm just wondering what the regulatory authorities are doing here. Behind all that, of course, I'm wondering, can Janssen, or Johnson & Johnson, keep up with what we all want to do?
Richter: All right, well, I love the topic because of course, that's how most things follow except elranatamb which was: approval, and then the Nature Medicine paper a day or 2 later, but with a lot of flair. I'm going to award you an equal 10 points for phenomenal answer. Dr Faiman, to you—what are you looking for [regarding an] upcoming for FDA approval?
Faiman: I have to jump on the bandwagon and go with cilta-cel as the next FDA approval. Earlier last year I wrote a paper about the ethical implications of selection of CAR T-cell therapy, we had these long waiting lists with CAR T-cell patients—84 at one time in my institution. We had to determine which criteria would award that person that slot; then that was ide-cel,and then cilta-cel, and then the biospecifics came and then blew it all up.
But I think there's still this issue even though cilta-cel and ide-cel might be on the cusp of approval, I still don't know what's going to happen. There's still people that can't access these therapies that are in their third plus line. Although it's going to be probably cilta-cel and ide-cel, I still think that there's this gap and this disparate population that doesn't get the drugs that they need. That's all.
Richter: Absolutely, you got your answer and just under the buzzer. We will not be taking questions at this time Dr Matous. Simply for the fact of you self-referencing an article that you did, right, I have to award your 10 points because that was expertly done.
