Leg­end im­proves ac­cess to Carvyk­ti, but cell ther­a­py lags de­mand as biotech seeks ear­li­er-line ap­proval

Leg­end Biotech and its part­ner John­son & John­son are seek­ing ap­proval to move their blood can­cer cell ther­a­py in­to ear­li­er lines of treat­ment, though the com­pa­nies have strug­gled so far to catch up to mar­ket de­mand.

The New Jer­sey biotech said Tues­day that the FDA will con­duct a stan­dard re­view, rather than a speedy one, as it seeks ap­proval for Carvyk­ti as a sec­ond treat­ment op­tion for pa­tients with mul­ti­ple myelo­ma. The FDA set a de­ci­sion dead­line of April 5, 2024, and Eu­ro­pean reg­u­la­tors al­so ac­cept­ed the ap­pli­ca­tion for an ex­pand­ed la­bel.

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