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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