Bristol Myers and 2seventy bio say FDA delayed CAR-T therapy decision

The FDA is de­lay­ing its de­ci­sion on whether to ap­prove Bris­tol My­ers Squibb and 2sev­en­ty bio’s CAR-T cell ther­a­py for mul­ti­ple myelo­ma in ear­li­er lines of treat­ment, and it plans to hold a pub­lic meet­ing with out­side ex­perts to dis­cuss.

The reg­u­la­tor was orig­i­nal­ly ex­pect­ed to make a de­ci­sion by Dec. 16 on whether to ap­prove Abec­ma for mul­ti­ple myelo­ma in adults whose can­cer re­turned af­ter al­ready re­ceiv­ing two to four pri­or reg­i­mens. Cur­rent­ly, the drug is ap­proved for mul­ti­ple myelo­ma pa­tients who have pre­vi­ous­ly had four or more lines of treat­ment.

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