Commentary
Video
Author(s):
Debra Patt, MD, PhD, MBA, and Houston Holmes, MD, discuss the ramifications of the FDA's removal of REMS requirements for approved chimeric antigen receptor (CAR) T-cell (CAR T) therapies.
In an interview with Pharmacy Times®, Debra Patt, MD, PhD, MBA, executive vice president of Texas Oncology and vice president of the Community Oncology Alliance, and Houston Holmes, MD, a physician at Texas Oncology with specialties in hematologic malignancies, discussed the FDA’s decision to eliminate Risk Evaluation and Mitigation Strategies (REMS) requirements for BCMA- and CD19-directed chimeric antigen receptor (CAR) T-cell (CAR T) therapies. Both clinicians emphasized throughout how improved understanding of side effects has made CAR T therapy safer and more manageable, laying the groundwork for continued integration into oncology care.
Pharmacy Times: The FDA recently removed the REMS requirements for all currently approved BCMA- and CD19-directed CAR-T therapies. From your perspective, what does this decision signal about how CAR-T therapies are now being viewed in terms of safety and standardization?
Debra Patt, MD, PhD, MBA: This is a great question. I think the FDA decision is important and really signifies the progress we've made in understanding the risks of these therapies and in clinicians recognizing reactions to CAR T therapies and managing them effectively. Mandating the REMS program for the 6 CAR T therapies that were recently removed from it was initially important. It ensured immediate availability of tocilizumab (Actemra; Genentech) to manage cytokine release syndrome (CRS) or other toxicities. That was crucial early on, because it wasn’t clear whether clinicians could appropriately recognize and manage those toxicities. Now that there's a great degree of familiarity with these products, there's confidence that we can manage the risks appropriately. Removing the REMS barrier is one step toward making these therapies more available to the patients we serve.
Pharmacy Times: Can you walk us through how CAR T therapy works, particularly for pharmacists and patients who may be less familiar with its mechanism and administration?
Houston Holmes, MD: Sure. It’s not a really short, simple answer, but I’ll try to be brief. These treatments use the patient’s own immune system. We collect lymphocytes—specifically T cells—from the patient’s blood. These T cells are manipulated in a lab or by the pharmaceutical company so that they recognize the patient’s cancer—in this case, lymphoma or multiple myeloma. The cells are then infused back into the patient to seek out and kill the cancer cells. In some situations, this can even be curative, especially for patients who don’t have other options. In others, it can provide a very effective, long-lasting remission. The process starts with a procedure called leukapheresis, where T cells are collected using an IV catheter and a machine that filters them out. It takes a few weeks to manufacture the cells into a CAR T product, which is then shipped back to the treatment center. Patients receive a brief course of chemotherapy beforehand, and then the cells are infused—usually as a single dose. There can be side effects, which was one reason for the REMS program, but we now understand how to manage them much better. That’s why the FDA has backed off on the REMS requirements.
Pharmacy Times: Do you think the removal of REMS could lead to earlier or broader use of CAR-T therapies?
Holmes: I think it's one step toward simplifying the process. CAR T therapy is expensive, logistically complicated, and comes with significant side effects. But most of these toxicities are manageable. To the extent that we can reduce regulatory and logistical burdens, yes, it can help. For example, the REMS program initially recommended patients not drive for a long time due to potential neurologic side effects. We now know those effects are not as long-lasting or common as previously thought. Patients were also recommended to stay at the treatment center for a month—that’s been shortened. All this simplifies the process and makes treatment more accessible.
Pharmacy Times: From a health equity standpoint, what are some of the systemic barriers this change could help dismantle—and what still needs to happen to fully close those gaps?
Patt: Great question. The removal of these therapies from the REMS program gives patients broader access. REMS was a barrier to therapy, so this is one step—but as Dr. Holmes mentioned, it’s part of a multi-step process. One of the biggest barriers is cost. Insurance reimbursement for CAR T therapy is often lower than the drug costs, creating a financial hurdle. Over time, we hope costs will decrease and reimbursement will improve to make it more accessible. We also don’t have a Dr. Houston Holmes everywhere. We need site-specific experts to make this treatment a reality. At Texas Oncology, we have cancer centers across the state, which is amazing—but we don’t offer CAR T in every location. Reimbursement needs to improve to make CAR T more widely accessible.
Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights.
