Up­dat­ed: FDA ad­comm backs ben­e­fits of Abec­ma and Carvyk­ti in ear­li­er pa­tients

An FDA ad­vi­so­ry com­mit­tee vot­ed on Fri­day that the ben­e­fits of two CAR-T ther­a­pies, Carvyk­ti and Abec­ma, out­weigh their risks in ear­li­er-stage mul­ti­ple myelo­ma pa­tients.

The vote was unan­i­mous for John­son & John­son and Leg­end Biotech’s Carvyk­ti. For Bris­tol My­ers Squibb and 2sev­en­ty bio’s Abec­ma, mem­bers vot­ed 8 to 3 in fa­vor of the ben­e­fit.

Both CAR-Ts are cur­rent­ly ap­proved as fifth-line treat­ments. But when asked to bring the ther­a­pies in­to ear­li­er lines, FDA re­view­ers raised con­cerns in brief­ing doc­u­ments about high­er rates of death in the first months of treat­ment among pa­tients who took the CAR-Ts com­pared with those who re­ceived stan­dard reg­i­mens.

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