Updated: FDA’s safety review on CAR-Ts culminates in new boxed warnings of secondary cancer
The FDA has told Novartis, Gilead, Bristol Myers Squibb and Johnson & Johnson to add boxed warnings on the labels of six CAR-T therapies noting the risks of secondary cancer.
The agency caused a stir in the CAR-T space when it revealed the safety review in November, which came as a surprise to many. Secondary cancers are a known but uncommon risk of many anti-cancer treatments; most scientists, clinicians and companies said they remain rare and are a relatively small risk factor for an otherwise effective drug class.
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