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 20 re­ports since the ap­proval of the first CAR-T ther­a­pies in 2017, in­clud­ing 15 from the FDA’s self-re­port­ing ad­verse event sys­tem known as FAERS.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER