"FDA Requires Boxed Warnings for Secondary Cancer in CAR-T Therapies"

The FDA has instructed several pharmaceutical companies to include boxed warnings on the labels of six CAR-T therapies, cautioning about the risks of secondary cancer. This move follows a safety review initiated by the agency in November, which has sparked discussions within the CAR-T space. While secondary cancers are a known but uncommon risk of many anti-cancer treatments, most experts believe they remain rare and represent a relatively small risk factor for an otherwise effective drug class.