FUCASO: Usoro mgbanwe zuru oke-mmadụ BCMA CAR-T na arụmọrụ na nchekwa enweghị atụ.
nkọwa ngwaahịa
FUCASO, nke Nanjing IASO Biotechnology mebere, bụ usoro ọgwụgwọ CAR-T na-emebi emebi nke emebere ka e wee gbado anya na antigen B-cell maturation antigen (BCMA). Usoro ọgwụgwọ a pụtara ìhè maka nrụpụta ụlọ ọgwụ na-enweghị atụ na profaịlụ nchekwa, na-enye olileanya ọhụrụ maka ndị ọrịa nwere nlọghachi azụ ma ọ bụ refractory multiple myeloma (r / rMM). Nkwenye nke National Medical Products Administration (NMPA) na June 30, 2023, FUCASO egosilarị nnukwu ihe ịga nke ọma na ngwa ụlọ ọgwụ.
Isi uru nke FUCASO
Ọnụego nzaghachi dị elu: FUCASO na-etu ọnụ ọnụ ọgụgụ nzaghachi zuru oke (ORR) nke 98.9% na nzaghachi zuru ezu (CR) nke 82.4%, dị elu karịa ọgwụgwọ ndị ọzọ dịnụ.
Mgbaghara na-adịgide adịgide: Ndị ọrịa na-emeso FUCASO egosila 12-ọnwa Ọganihu-Nlanahụ N'efu (PFS) ọnụego nke 85.5%, na-egosi mgbaghara ogologo oge na mma ndụ.
Profaịlụ nchekwa: Na ≥3 grade Cytokine Release Syndrome (CRS) na-eme na naanị 1% nke ndị ọrịa na enweghị akụkọ gbasara ≥3 grade Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), FUCASO na-enye nhọrọ ọgwụgwọ dị nchebe ma e jiri ya tụnyere usoro ọgwụgwọ CAR-T ndị ọzọ.
Ọnụ-arụmọrụ: Ọgwụgwọ FUCASO na-efu nke ukwuu karịa usoro ọgwụgwọ ndị yiri ya dị na United States, na-eme ka ọ bụrụ nhọrọ dị mma maka ọtụtụ ndị ọrịa.
Nweta zuru ụwa ọnụ: IASO BIO eguzobewo ụlọ ọrụ nlekọta ahụike zuru oke na China, nke nwere ike ijere ndị ọrịa si gburugburu ụwa na-arụ ọrụ na-arụkọ ọrụ ọnụ site na ndụmọdụ na nlekọta nlekọta ọgwụgwọ.
Ihe ịga nke ọma ụlọ ọgwụ
Onye ọrịa mbụ a na-emeso ya na FUCASO enwetala afọ ise nke ndụ na-enweghị ọrịa cancer, ihe dị ịrịba ama dị ịrịba ama ma e jiri ya tụnyere Median Progression-Free Survival (PFS) nke nanị ọnwa 2.9 na nlekọta ọkọlọtọ. Nke a na-akọwapụta ikike FUCASO nwere ịgbanwe mpaghara ọgwụgwọ maka otutu myeloma.
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