Bris­tol My­ers and 2sev­en­ty bio's Abec­ma sur­vival da­ta raise ques­tions ahead of FDA’s ad­vi­so­ry com­mit­tee meet­ing: #ASH23

SAN DIEGO — The FDA in No­vem­ber de­layed its de­ci­sion on whether to ap­prove Bris­tol My­ers Squibb and 2sev­en­ty bio’s CAR-T cell ther­a­py for ear­li­er lines of mul­ti­ple myelo­ma treat­ment.

Now, new da­ta show why the FDA plans to gath­er an ad­vi­so­ry com­mit­tee to re­view over­all sur­vival da­ta from the ther­a­py’s piv­otal tri­al.

At the Amer­i­can So­ci­ety of Hema­tol­ogy meet­ing on Mon­day, the com­pa­nies pre­sent­ed da­ta from their Phase III Kar­M­Ma-3 study. Pa­tients who got Abec­ma saw their risk of death cut by 31% com­pared to those who re­ceived stan­dard treat­ment, when the re­sults were sta­tis­ti­cal­ly ad­just­ed to ac­count for the fact that 56% of pa­tients from the stan­dard care arm crossed over to re­ceive Abec­ma af­ter their can­cers pro­gressed. While the ad­just­ed re­sults trend­ed to­ward a sur­vival ben­e­fit, they were not sta­tis­ti­cal­ly sig­nif­i­cant.

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