FDA rais­es con­cerns of 'ear­ly death­s' in Abec­ma and Carvyk­ti mul­ti­ple myelo­ma tri­als

An FDA ad­vi­so­ry com­mit­tee will vote Fri­day on whether two CAR-T ther­a­pies, Carvyk­ti and Abec­ma, have a fa­vor­able ben­e­fit-risk ra­tio in ear­li­er lines of mul­ti­ple myelo­ma treat­ment. But reg­u­la­tors say ear­ly deaths among those who re­ceived the cell ther­a­pies in tri­als cre­ate un­cer­tain­ty around their ben­e­fit in those in­di­ca­tions.

Abec­ma and Carvyk­ti are cur­rent­ly ap­proved as fifth-line treat­ments for mul­ti­ple myelo­ma, a blood can­cer that caus­es most pa­tients to even­tu­al­ly re­lapse. Bris­tol My­ers Squibb and 2sev­en­ty bio have ap­plied to move Abec­ma, al­so known as ide-cel, up to the third-line set­ting, high­light­ing the im­por­tance of us­ing “the most ef­fec­tive ther­a­pies ear­ly in the treat­ment par­a­digm.”

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