FDA’s Peter Marks says some secondary cancer cases after CAR-T therapy may be ‘causal,’ but benefits still outweigh risks: #JPM24

The FDA be­lieves that the ben­e­fit of CAR-T ther­a­pies con­tin­ues to out­weigh their risks amid an on­go­ing in­ves­ti­ga­tion on cas­es of sec­ond blood can­cers de­vel­op­ing in pa­tients who re­ceive the cell ther­a­pies, ac­cord­ing to se­nior FDA of­fi­cial Pe­ter Marks.

The FDA is now in­ves­ti­gat­ing 22 cas­es of blood can­cer de­vel­op­ing af­ter CAR-T cell ther­a­py treat­ment, said Marks, the di­rec­tor of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, on Mon­day at an Al­liance for Re­gen­er­a­tive Med­i­cine event. “Al­though se­quenc­ing is not avail­able for all of them, in at least a few of the cas­es we know that the CAR con­struct is in the ma­lig­nant clone, which re­al­ly sug­gests that there was prob­a­bly an as­so­ci­a­tion there,” Marks said.

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