FDA loosens side effect reporting requirements for some CAR-T therapies

The FDA is no longer requiring the reporting of two common — and sometimes serious — side effects for a handful of CAR-T therapies in an effort “to minimize the burden on the healthcare delivery system.”

The immune system overreaction known as cytokine release syndrome (CRS), and neurologic toxicities are two well-known side effects of CAR-T treatment. Last week, regulators removed a requirement for clinicians to report serious cases of the side effects as part of its Risk Evaluation and Mitigation Strategies for Gilead’s treatments Yescarta and Tecartus.

The agency approved similar updates in March for Bristol Myers Squibb’s Breyanzi, and in April for Bristol Myers and 2seventy bio’s Abecma, respectively.

James Kochenderfer

James Kochenderfer, a senior investigator at the National Cancer Institute, told Endpoints News on Tuesday that it’s reasonable to reduce…
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