China approves BCMA CAR-T therapy for multiple myeloma, with Innovent beating Legend in race to be first

In­novent and IA­SO Bio re­ceived the first ap­proval in Chi­na for a CAR-T ther­a­py for mul­ti­ple myelo­ma.

The ther­a­py, known as eque­cab­ta­gene au­toleu­cel, will be mar­ket­ed as Fu­ca­so, In­novent an­nounced Sun­day. It is in­di­cat­ed for pa­tients with mul­ti­ple myelo­ma that has re­turned or pro­gressed af­ter at least three pre­vi­ous treat­ments, in­clud­ing with a pro­tea­some in­hibitor and an im­munomod­u­la­to­ry drug.

In clin­i­cal tri­als, about three-quar­ters of the 101 evalu­able pa­tients went in­to re­mis­sion af­ter re­ceiv­ing the CAR-T ther­a­py. At one year, the pro­gres­sion-free sur­vival rate was 78.8%. One pa­tient ex­pe­ri­enced grade 3 cy­tokine re­lease syn­drome — an im­mune storm that hap­pens in re­ac­tion to CAR-T treat­ment — and two ex­pe­ri­enced grade 1 or 2 ICANS — neu­ro­tox­i­c­i­ty al­so re­lat­ed to CAR-T treat­ment.

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