On January 23, 2024, Legend Biotech announced that applications seeking to expand the use of CARVYKTI® in earlier lines of treatment for relapsed/refractory multiple myeloma supported by results from the Phase 3 CARTITUDE-4 study have been referred to health authority advisory committees, specifically: The U.S. Food and Drug Administration?s (FDA) Oncologic Drugs Advisory Committee (ODAC) intends to meet to review data supporting the supplemental Biologics License Application for CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for 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 date of the ODAC meeting will be announced in the Federal Register. The European Medicines Agency Committee for Advanced Therapies (CAT) will convene a Scientific Advisory Group Oncology (SAG-O) meeting to review data supporting the submission of a Type II variation application seeking expanded use of CARVYKTI® in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.

The date of the SAG-O meeting has not yet been announced by the CAT.