If you or a loved one has been exploring treatment options for relapsed or refractory multiple myeloma, you may have heard of CAR T-cell therapy—a highly effective treatment option that reprograms your own immune system to fight cancer.
In a pivotal move, the FDA recently removed the Risk Evaluation and Mitigation Strategy (REMS) requirements for CAR T-cell therapies used in multiple myeloma. REMS are specialized safety programs that CAR T centers must follow to minimize the risk associated with the treatment. Other treatments for multiple myeloma have REMS programs in place.
This decision marks a major shift in how these therapies can be delivered—and it’s one that could open doors for patients who were previously unable to benefit from CAR T.
Limited treatment centers, burdensome pre-approvals, and strict inpatient administration rules have made CAR T difficult to access for many patients and providers. By removing REMS, the FDA has helped streamline the pathway to treatment.
One of the most promising effects of this change?
Reaching patients who’ve been historically underserved.
Right now, only about 20% of eligible myeloma patients receive CAR T therapy, largely due to where they live. Patients in rural or underserved areas often face long-distance travel and financial hurdles that put CAR T out of reach. Without REMS, more treatment centers can begin offering CAR T, potentially improving access in these regions and allowing more patients to receive timely care.
As CAR T becomes more accessible, the MMRF sees even greater opportunities on the horizon. This momentum is essential in our mission to accelerate precision medicine and improve outcomes for all myeloma patients.
The FDA’s decision is more than a policy shift. It’s a signal of trust in the hematology/oncology community. It shows that providers have demonstrated the knowledge and experience needed to manage the risks associated with CAR T, such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), without the need for special certifications or safety checks.
If CAR T isn’t an option for you because of where you live, this change could be the turning point. Now is the time to speak with your care team about whether CAR T is a fit for you, and to revisit clinical trial opportunities that may have been previously out of reach.
You can ask your doctor:
For more support and guidance, the MMRF Patient Navigation Center is here to help you understand your options, connect to care, and navigate the next steps in your myeloma journey.
