CBER Director Peter Marks (Greg Nash/Pool via AP Images)

Fol­low­ing CAR-T safe­ty la­bel changes, FDA of­fi­cials share new de­tails about sec­ondary can­cer cas­es

More than half of the can­cer cas­es the FDA is ex­am­in­ing as part of its CAR-T safe­ty in­ves­ti­ga­tion oc­curred with­in two years of treat­ment, ac­cord­ing to an ed­i­to­r­i­al penned by top FDA of­fi­cials and pub­lished Wednes­day.

The FDA is in­ves­ti­gat­ing 22 cas­es of T cell can­cers de­vel­op­ing af­ter pa­tients un­der­went CAR-T cell ther­a­py treat­ment, the FDA’s Nicole Ver­dun and Pe­ter Marks wrote in the New Eng­land Jour­nal of Med­i­cine. The ed­i­to­r­i­al echoes some of the in­for­ma­tion pre­vi­ous­ly shared by Marks, who over­sees the reg­u­la­tion of cell and gene ther­a­pies at the FDA, at an event ear­li­er this month.

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