FDA reduces risk reporting for CAR T cells to ‘minimize the burden’ on providers
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FDA has scaled back its Risk Evaluation and Mitigation Strategy reporting requirements for providers of chimeric antigen receptor T-cell therapies.
The regulator will no longer require that health care staff receive educational and training materials about the risk for cytokine release syndrome and neurotoxicity associated with their use. It also removed the requirement to report suspected cases of CRS and neurotoxicity to the FDA.
The revision applies to six autologous CAR T-cell therapies, including four CD19-directed and two B-cell maturation antigen-directed agents.
The Risk Evaluation and Mitigation Strategy (REMS) is the FDA’s risk management program that restricts use of certain treatments with safety concerns.
“FDA determined that the approved REMS for these products must be modified to minimize the burden of complying with the REMS on the health care delivery system,” the FDA said in a press release. “Currently, information regarding the risks for CAR T-cell immunotherapies can be conveyed adequately via the current product labeling, which includes a boxed warning for the risks [for] CRS and neurological toxicities, and the Medication Guides [that] are a part of the approved labeling.”
The decision to reduce the REMS requirements for CAR-T providers has two major implications, according to Marcela V. Maus, MD, PhD, director of the cellular immunotherapy program at Massachusetts General Hospital Cancer Center and Healio | HemOnc Today Associate Medical Editor.
“It solidifies the placement of CAR T-cell therapies as a standard treatment for patients, and reduces the administrative burden on clinicians and teams who are providing this groundbreaking therapy,” she told Healio.
“Because CAR T-cell therapy was a relatively new development a decade ago — and first approved as a standard therapy in the U.S. in 2017 — there was significant oversight at multiple levels to make sure that patients were being monitored carefully and sites had significant training, and coupled with that were significant reporting requirements,” she added. “Now that these therapies have become more established, and there are systems, guidelines and standards in place, professional societies and regulatory bodies have come together to modify the federal REMS to minimize the burden on health care personnel.”
The modified REMS continues the original biologic license application approval requirement that providers have at least two doses of tocilizumab (Actemra, Genentech) on-site and with immediate access for each patient receiving CAR T cells. The interleukin-6 receptor antagonist is used as supportive care to help reduce inflammation associated with CAR-T-induced CRS and neurotoxicity.
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