Omar Nadeem, MD, Clinical Director of the Myeloma Immune Effector Cell Therapy Program and Center for Early Detection and Interception of Blood Cancers at Dana-Farber Cancer Institute; Nausheen Ahmed, MD, a hematologist-oncologist and associate professor in the Division of Hematologic Malignancies and Cellular Therapeutics at The University of Kansas Cancer Center; and Forat G Lutfi, MD, an assistant professor in the Division of Hematologic Malignancies and Cellular Therapeutics at The University of Kansas Cancer Center, provided insights on the FDA’s decision to eliminate Risk Evaluation and Mitigation Strategies (REMS) requirements for all currently approved CD19- and BCMA-directed autologous CAR T-cell immunotherapies in hematologic malignancies.
This decision, which was announced on June 27, 2025, is expected to expand access to these therapies by reducing longstanding socioeconomic, geographic, and logistical barriers, experts explained when interviewed by OncLive®.
Watch the video or read the transcript below to learn more about how this regulatory change is expanding patient access by reducing monitoring requirements and logistical burdens, while also fostering the development of hybrid care models that integrate community oncology centers into the delivery of this curative therapy. For a more in-depth look at the factors informing the removal of this safeguard and its implications for real-world oncology practice, check out our feature article.
Nadeem: The REMS requirement is no longer there for CAR T-cell therapy, which is going to be huge. Before, that was one of the reservations patients had. They could not drive for 2 months. They needed a caregiver for [1] month. These things were real barriers [to CAR T-cell therapy]. To patients going forward with this therapy, it seems much more doable for the majority of patients and their caregivers. They can take that time to get through this, and then they can go back to their community.
Ahmed: When CAR T[-cell therapy first] emerged back in 2017, just a few centers were doing it. Now it has expanded, but we know that there’s [still] room for improvement. It’s not out there in the community. When the REMS [protocols] first came about, monitoring focused on cytokine release syndrome [CRS] and immune effector cell–associated neurotoxicity syndrome [ICANS].
Lutfi: Traditionally, REMS training is required for providers and for people who are interacting with patients, and that is a time and financial barrier. It is hard for a lot of smaller-scale centers to adopt any therapy like CAR T [when] those requirements and restrictions [are in place]. The additional monitoring time period was also quite restrictive. Most centers would keep people locally for 30 days, some a little less, but that was generally what has been done. Additionally, the driving requirements, which previously lasted 8 weeks, were also restrictive for patients and limited the ability for patients who just could not do that, whether it was getting groceries or whatever was required of them.
Ahmed: This regulatory change is a huge deal. It surprised many of us that it came so fast, and we were impressed with that. We have already started making progress toward implementing it. Patients are now able to drive after 2 weeks, as long as they are stable, and they are able to go back home as long as they are stable. We are involving our community oncologists and referring oncologists earlier, and they are willing to take it on. There is more flexibility, which we love, and the patients love it.
Lutfi: As we get more comfortable and we see all these safety parameters, the risk of truly getting high-grade CRS and ICANS after 2 weeks is quite low. Most studies show [an incidence of] less than 1% to 2% [after 2 weeks post-infusion]. As we see that things are being done more safely, we are going to keep reducing the requirements and hoops that patients and their caretakers have to jump through.
Our plan is to move step by step, starting with some of our affiliated community sites. I visit some of them, and that would allow the first rollout. What we are hoping to do is shift some of the preparation and work-up for CAR T—which usually takes weeks before infusion—into the community sites. That way, when patients need echocardiograms, imaging, or other work-up that we traditionally kept at the main campus, we can do it in the community. The infusion process will still be done at the main center.
We have been giving bispecific [antibodies] in the community for over 2 years now, and [community clinicians] are very comfortable. The patients selected for community rollout [of CAR T-cell therapy] will be lower-risk or average-risk patients. We are not saying every [patient getting] CAR T should be managed in the community. Patients with primary refractory disease or relapsed, very high–risk disease, with very high risk for toxicity and complications, should not be treated in the community. Patient selection is an important factor.
Nadeem: We are moving quickly to adopt these changes since the REMS requirements were dropped. To be honest, I do not think [toxicity management] is going to change too much, because most toxicities occur within that 2-week window [after infusion]. CRS usually occurs within a week and is typically resolved by day 14. If it is not, we keep the patient until it is resolved. The more acute neurological toxicities are also usually resolved by that time point. Delayed neurological toxicities can occur weeks to months later, so that is not affected by the monitoring window.
Nadeem: The CRS timeline is fairly reliable. We can see inflammatory markers rise, and when patients develop chills or other signs, we know CRS is coming. At that point, we typically admit them around day 7, and they may stay until day 10 or 11. That means they are in the hospital for 3 days instead of 10 days, which has made a big difference for patients.
As a result, we have had to make sure we have enough providers, lab monitoring, and nursing support. It takes a whole team effort to guide management of these toxicities. It has been very smooth, and I think it will only get better over time.
Ahmed: As referring oncologists get more comfortable with CAR T-cell therapy, they will hopefully advocate for it more, and we will likely see more patients treated with CAR T-cell therapy.