FDA opens review of CAR-T safety after identifying 19 cases of post-treatment blood cancer

The FDA is re­view­ing the safe­ty of CAR-T ther­a­pies af­ter re­ports of pa­tients who de­vel­oped blood can­cers fol­low­ing treat­ment with the prod­ucts, an in­quiry that’s al­most cer­tain to raise ques­tions about the class as its de­vel­op­ers seek to ex­pand its use.

The agency told End­points News that it has re­ceived 19 re­ports since the ap­proval of the first CAR-T ther­a­pies in 2017, in­clud­ing 14 from the FDA’s self-re­port­ing ad­verse event sys­tem known as FAERS.

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