Fol­low­ing FDA in­quiry in­to CAR-T safe­ty, agency adds warn­ing on sec­ondary can­cers for Carvyk­ti

The FDA has added a black box warn­ing to John­son & John­son and Leg­end Biotech’s CAR-T treat­ment Carvyk­ti as the agency con­tin­ues to in­ves­ti­gate rare cas­es of sec­ondary blood can­cers im­pact­ing the en­tire drug class.

The boxed warn­ing now in­cludes a cau­tion against “sec­ondary hema­to­log­i­cal ma­lig­nan­cies, in­clud­ing myelodys­plas­tic syn­drome and acute myeloid leukemia,” Leg­end said in a se­cu­ri­ties fil­ing last week. The up­date was trig­gered by 10 re­ports of the can­cers (or in some cas­es both) out of the 97 pa­tients treat­ed in the Phase Ib/II CAR­TI­TUDE-1 tri­al, ac­cord­ing to Leg­end. Nine of those pa­tients died.

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