ASH 2024 | Current driving restrictions after Week 4 post-CAR T-cell therapy appear unnecessary

For CAR-T therapy, you know, across malignancies, not just myeloma, but also lymphoma, B-cell ALL, and others, it’s been a game changer for our patients, remarkably so. It’s been around for almost a decade. In the early days of CAR-T, some of these products had a risk of seizures, and so the FDA set guidance that the patients should not drive or operate heavy machinery for eight weeks after CAR-T therapy, that is both in the US and European guidelines. And that has perpetuated for the last decade. And now it is in every package insert for every single CAR-T therapy product. 

Interestingly, the ones in myeloma, there really have been no seizures in the KarMMa 3 or CARTITUDE 4 trial. And the co-stimulator domain they use, 4-1BB, is at lower risk of putting patients at risk of having seizures to begin with. And we put patients in a weird scenario where we tell them that you have to, you know, be within the CAR-T driving distance center, be as close to the CAR-T center for four weeks after CAR-T therapy. That makes sense because of cytokine release syndrome, because of fatigue, because of neurotoxicity or confusion. And after that, they’re free to go home, but not free to drive or operate heavy machinery for another four weeks thereafter. It’s just a weird discussion to have with patients, and it’s not really evidence-based. 

So we looked at data from the US Multiple Myeloma Immunotherapy Consortium, which is a group of 14 to 15 US academic centers that contribute data together to help our patients. I mean, two things. One, we actually looked at our outcomes for patients who got CAR-T therapy and tried to see what weird complications happened between weeks five through eight to begin with. Second, we interviewed physicians within the consortium to see what they think about this FDAbrestriction of driving restrictions. 

And in brief, less than 1% of cases, of patients, had any sort of untoward side effects between weeks five through eight after CAR-T therapy, primarily infections and progressive myeloma, no seizures. I would argue that if someone has an infection between weeks five through eight, one, it doesn’t mean they cannot drive, and two, if they feel quite fatigued, they probably would stop driving on their own, right? And so it doesn’t really make sense to mandate no driving for these patients because it’s hard for them. It gives disparities that patients have had to cobble together a caregiver support network for the entirety of CAR-T therapy four weeks afterwards, but now are not able to drive on their own, so still dependent on another four weeks thereafter. 

Unsurprisingly, in brief, we interviewed our physicians and they felt the exact same way. Between weeks one through four after CAR-T therapy, absolutely driving restrictions made sense. Between weeks five through eight, they did not make sense. Is this practice changing? Technically no, because the FDA and the EMA package inserts and guidance remain the same. However, we’re trying to take this information to the FDA and say, look, if you want an evidence-based package insert, adopt this. Make all the restrictions, reasonable restrictions, end at week four by default unless there’s some specific scenario that applies to that patient. Then I think that will, one, just make life easier for our physicians, make life easier for the community physicians who take our patients back after week four, and most importantly, make life easier for our patients, again, who have had to overcome so many logistical barriers to get to CAR-T therapy and to get rid of this extra barrier to not be able to drive from weeks five through eight thereafter.

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