FDA Oncologic Drugs Advisory Committee recommends Carvykti (ciltacabtagene autoleucel) for the earlier treatment of patients with relapsed or refractory multiple myeloma – Johnson & Johnson

Johnson & Johnson announced that the FDA Oncologic Drugs Advisory Committee (ODAC) recommends 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 who are refractory to lenalidomide.

The committee reviewed survival and safety data from the Phase III CARTITUDE-4 study and voted unanimously in favor of Carvykti (11 to 0) finding the risk-benefit assessment of Carvykti 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 Prescription Drug User Fee Act (PDUFA) date of April 5, 2024.

The committee reviewed data from the CARTITUDE-4 study, the first randomized Phase III study of Carvykti, which evaluated 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 who received one to three prior lines of therapy. These data also served as the basis for the recent European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion of a Type II variation for Carvykti in the treatment of patients with relapsed and refractory multiple myeloma who have received at least one prior therapy, including an IMiD and a PI, and are refractory to lenalidomide. Results from the CARTITUDE-4 study were initially presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine ( previously cited).

“Multiple myeloma is a disease with high unmet need as patients experience relapse or become refractory to treatments over time,” said Sundar Jagannath, M.D., Director of the Center of Excellence for Multiple Myeloma and Professor of Medicine, Hematology and Medical Oncology, Mount Sinai. “The availability of a cellular therapy like cilta-cel that can be used earlier in the treatment of this progressive disease is critically important, offering patients a chance of deep and durable responses with a one-time infusion.”

The ODAC is convened upon request of 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; however, final decisions on approval of the drug are made by the FDA.