Clin­i­cians say ben­e­fits of CAR-T con­tin­ue to out­weigh risk of T-cell ma­lig­nan­cies

A day af­ter the FDA launched an in­ves­ti­ga­tion in­to rare cas­es of sec­ondary blood can­cer in pa­tients who re­ceived CAR-T ther­a­pies, clin­i­cians are call­ing it a small risk fac­tor for an oth­er­wise ef­fec­tive drug class.

Reg­u­la­tors are track­ing 20 re­ports of T-cell ma­lig­nan­cies since the first CAR-Ts were ap­proved in 2017, in­clud­ing 15 from the FDA’s self-re­port­ing ad­verse event sys­tem FAERS. In the con­text of the tens of thou­sands of pa­tients who’ve re­ceived CAR-T ther­a­pies, that small num­ber rep­re­sents “an ex­treme mi­nor­i­ty,” UChica­go fac­ul­ty physi­cian and Hematopoi­et­ic Stem Cell Trans­plan­ta­tion Pro­gram di­rec­tor Michael Bish­op told End­points News on Wednes­day.

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