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BioWorld - Sunday, March 1, 2026
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Home » FDA expands Legend, J&J’s Carvykti with ‘best-case’ label in MM
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FDA expands Legend, J&J’s Carvykti with ‘best-case’ label in MM

April 8, 2024
By Jennifer Boggs
Following the U.S. FDA’s expansion of competing BCMA-targeting CAR T therapy Abecma (idecabtagene vicleucel) to include third-line and later treatment in multiple myeloma (MM) patients, the agency cleared Carvykti (ciltacabtagene autoleucel) from Legend Biotech Corp. and Johnson & Johnson’s Janssen unit for use in MM patients as early as second-line treatment. The label, which RBC Capital Markets analyst Leonid Timashev called a “best-case scenario,” includes no notable updates to the black box warning and should help accelerate and expand Carvykti’s update in the U.S., with 2024 revenues expected to top $950 million.
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