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

However, the FDA said the benefits of the treatment still outweigh the risks.

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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.