FDA approves J&J and Legend’s Carvykti for second-line multiple myeloma

The FDA has ex­pand­ed the la­bel for John­son & John­son and Leg­end Biotech’s mul­ti­ple myelo­ma CAR-T ther­a­py to make it a much ear­li­er treat­ment op­tion for pa­tients, J&J an­nounced late Fri­day night.

The reg­u­la­tor ap­proved Carvyk­ti for mul­ti­ple myelo­ma pa­tients who have re­ceived at least one pri­or line of ther­a­py. The cell ther­a­py was first ap­proved in 2022 as a fifth-line op­tion, mak­ing it avail­able on­ly to pa­tients who’d al­ready ex­haust­ed many of their treat­ment choic­es. It gen­er­at­ed $500 mil­lion in glob­al sales last year, and TD Cowen an­a­lysts ex­pect the ther­a­py to bring in $950 mil­lion in sales this year fol­low­ing the la­bel ex­pan­sion.

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