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 KochenderferJames Kochenderfer, a senior investigator at the National Cancer Institute, told Endpoints News on Tuesday that it’s reasonable to reduce the reporting requirements because the field has collected extensive data from thousands of patients, and has developed guidelines for treating CRS and neurologic toxicity.
“Over the years, we’ve learned more and more about treating CRS and neurologic toxicity,” said Kochenderfer, who has received research funding from both Bristol Myers and Gilead. “The toxicities now are substantially milder than they used to be because of early treatment.”
The agency also removed other requirements from the Tecartus and Yescarta REMS, including for educational and training materials such as an adverse reaction management guide.
“As CAR T-cell therapy has become a more standard treatment, the knowledge, skills, and experience needed to provide CAR T safely and effectively have grown during this time, and oncologists can appropriately manage the side effects,” a Gilead spokesperson said.
CAR-T safety has been in the spotlight this year, after the FDA probed rare reports of T cell malignancies in patients who’ve taken CAR-Ts and determined in April that boxed warnings are necessary.