FDA Seeks New Boxed Warning for CAR-T Cancer Therapies After Cancer Risk Reports

Published on January 24, 2024

The U.S. Food and Drug Administration has issued a ruling requiring manufacturers of certain cancer drugs to add boxed warnings—the agency’s most serious safety label—to labeling, saying they may actually increase the risk of cancer. The ruling targets makers of specialized therapies called CAR-T immunotherapies that are used to treat certain blood cancers. Newly Altered Cells May Later Cause Cancer Boxed warnings signify that a drug carries significant risks of life-threatening or otherwise serious adverse effects. Specifically, manufacturers developing six CAR-T treatments aimed at the CD19 protein must now include prominent boxed warnings that highlight the risk excessive immune response and neurotoxicity. The ruling applies to several leading CAR-T treatments including: Bristol Myers Squibb’s Breyanzi and Abecma; Johnson & Johnson’s Carvykti; Novartis’ Kymriah; and Gilead’s Tecartus and Yescarta....

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