July 16, 2025
In 2025, the FDA made a major change that could help thousands more cancer patients access CAR T-cell therapy. Behind that decision was a team of researchers at The University of Kansas Cancer Center, whose work helped lead to that change.
Barriers to treatment
CAR T-cell therapy has been a game-changer for patients with certain blood cancers. But until recently, patients had to stay near a treatment center for four weeks after receiving the therapy and were barred from driving for eight weeks. These rules, part of a federal safety program known as REMS (Risk Evaluation and Mitigation Strategies), were designed to catch rare but dangerous side effects early.
But for many patients, especially those who lived far from major hospitals or couldn’t afford to take time off work, these rules made treatment nearly impossible. Previous studies have shown that just 20% to 30% of patients who are eligible for CAR T are eventually able to receive therapy.
“We witnessed patients being left behind,” said Nausheen Ahmed, MD, a hematologist and lead author of several key studies. “No one was really asking why these rules were in place, or whether they were still necessary.”
Asking the right questions
In 2022, Dr. Ahmed and her team published a study showing clear issues in who could access CAR T-cell therapy. Some groups of patients were far less likely to receive the treatment. They followed up with two more studies in 2024, one focusing on myeloma and the other on lymphoma, that asked a critical question: Was the four-week monitoring period actually needed?
The team found that most serious side effects, like cytokine release syndrome and neurotoxicity, happen within the first two weeks. After that, the main risks are infections, not the side effects REMS was designed to monitor. Patients who were stable after two weeks were very unlikely to develop new serious complications.
“We went in with an open mind,” said Dr. Ahmed. “But the data showed that two weeks of monitoring was enough. The four-week rule was doing more harm than good.”
Evidence leads to FDA decision
In mid-2025, the FDA announced it was eliminating the REMS requirements for all approved CAR T-cell therapies. Patients now only need to stay near their treatment center for two weeks and driving restrictions have also been shortened to two weeks.
This change is expected to improve access, especially for patients who previously couldn’t afford to travel or stay near a hospital for a month. While many institutions and researchers contributed to the growing body of evidence that informed the FDA’s decision, KU Cancer Center’s early work helped catalyze the conversation. The team’s studies were among the first to connect access issues with the need to reevaluate monitoring requirements.
“It’s gratifying,” said Dr. Ahmed. “We helped identify the problem and proposed a solution. Now that solution is part of national policy.”