European regulator recommends approval of Carvykti in earlier lines of multiple myeloma

A Eu­ro­pean Med­i­cines Agency com­mit­tee rec­om­mend­ed that the la­bel for Leg­end Biotech and John­son & John­son’s CAR-T Carvyk­ti be ex­pand­ed to mul­ti­ple myelo­ma pa­tients as a sec­ond-line op­tion, Leg­end an­nounced Fri­day morn­ing.

If rat­i­fied by Eu­ro­pean reg­u­la­tors, the ex­pand­ed la­bel could un­lock a much larg­er el­i­gi­ble pa­tient pop­u­la­tion for Carvyk­ti. The EMA’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use (CHMP) rec­om­mend­ed that Carvyk­ti be ap­proved for pa­tients whose mul­ti­ple myelo­ma has come back or stopped re­spond­ing to ther­a­py and who have re­ceived at least one pre­vi­ous treat­ment reg­i­men.

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