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# Legend Bio sBLA to Expand Carvykti’s Use
- URL: https://www.fdaweb.com/legend-bio-sbla-to-expand-carvyktis-use/
- Published: 2023-06-07T12:00:00.000Z
- Updated: 2026-09-14T18:37:10.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5154634

Legend Biotech has submitted a supplemental BLA seeking to expand the label for Carvykti (ciltacabtagene autoleucel) to include the treatment of adult patients 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.

The submission is based on data from the CARTITUDE-4 study ([NCT04181827](https://clinicaltrials.gov/ct2/show/NCT04181827?term=JNJ-68284528&phase=2&draw=2&rank=1&ref=fdaweb.com)), a Phase 3 study evaluating the efficacy and safety of cilta-cel versus standard of care regimens in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, according to the company. It met its primary endpoint of showing a statistically significant improvement in progression-free survival compared to standard therapy at the first pre-specified interim analysis, the company says, adding that as a result, an independent data monitoring committee recommended unblinding the study.

Carvykti is described as a B-cell maturation antigen-directed genetically modified autologous T cell immunotherapy. It is currently indicated for treating adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.