International approvals of cilta-cel: a lens on CAR T cell regulation.
No abstract available
COI Statement
Competing interests: The authors declare no competing interests.
References:
Yin, C. et al. Gene and cell therapies in China: booming landscape under dual-track regulation. J. Hematol. Oncol 15, 139 (2022).
Berdeja, J. G. et al. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet 398, 314–324 (2021).
US Food and Drug Administration. Carvykti. fda.gov https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/carvykti (2024).
European Medicines Agency. Carvykti. ema.europa.eu https://www.ema.europa.eu/en/medicines/human/EPAR/carvykti (2024).
Pharmaceuticals and Medical Devices Agency. Report on the deliberation results-Carvykti. pmda.go.jp https://www.pmda.go.jp/files/000252610.pdf (2022).