Legend and J&J seek earlier Carvykti approval in multiple myeloma indication

8 June 2023

Legend Biotech (Nasdaq: LEGN) and Janssen have announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) relating to their partnered asset Carvykti (ciltacabtagene autoleucel).

The sBLA seeks to expand the label of the BCMA-directed CAR-T therapy to include the treatment of adults with relapsed and lenalidomide-refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.

"This submission brings us one step closer to potentially helping more patients facing relapsed and refractory multiple myeloma, as we continue to explore the potential of Carvykti"At present, Carvykti is approved in the USA in this group after at least four lines of therapy.

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