FDA updates Gilead's label for CAR-T Tecartus with new boxed warning for secondary cancer
The FDA on Monday pulled but then updated and published a new letter to Gilead advising that its CAR-T drug Tecartus does need a boxed warning for secondary cancer, reaffirming that this is a class-wide risk in the eyes of the regulatory agency.
Last week, the FDA told Novartis, Gilead, Bristol Myers Squibb and Johnson & Johnson to add boxed warnings on the labels of all six currently marketed CAR-T therapies. At the first publication, five of the six letters had warnings that said T cell malignancies “have occurred following treatment with BCMA- and CD19- directed genetically modified autologous T cell immunotherapies.”
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