Legend Biotech Corporation announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended CARVYKTI®? (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and are refractory to lenalidomide. The positive recommendation follows the committee's evaluation of efficacy and safety data from the Phase 3 CARTITUDE-4 study.

The committee voted unanimously in favor of CARVYKTI (11 to 0) finding the risk-benefit assessment of cilta-cel for the proposed indication as favorable. A supplemental Biologics License Application (sBLA) supported by the CARTITUDE- 4 study is currently under review by the FDA with a target Prescription Drug User Fee Act (PDUFA) date of April 5, 2024. The committee reviewed results from the CARTITUDE -4 study (NCT04181827), the first randomized Phase 3 study evaluating the efficacy and safety of CARVYKTI versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone ("DPd") in the treatment of patients with relapsed and lenalidomide-refractory multiple myeloma where have received one to three prior lines of therapy.

Outcomes from the Phase 3 CARTitUDE-4 study were first presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. These study results also supported the recent European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion for CARVYKTI in adult patients with relapsed or Refractory multiple myelomide who have received at least one previous line of therapy including a prote asome inhibitor (PI) and a immunomodulatory agent (imiD), have demonstrated disease progression on the last therapy and are refractory to lenalidomide. The ODAC is assembled upon request from the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of oncologic diseases.

The committee provides non-binding recommendations based on its evaluation; final decisions on approval of the drug are made by the FDA. CARVYKTI®®?INDICATIONS AND USAGE: CARVYKTI®?? (ciltacab tagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of 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.

CARVYKTI®? is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI?? REMS Program.