FUCASO: ʻO ka Revolutionary Fully-Human BCMA CAR-T Therapy me ka maikaʻi ʻole a me ka palekana.
ʻO FUCASO, i hoʻomohala ʻia e Nanjing IASO Biotechnology, kahi lāʻau lapaʻau CAR-T i hoʻolālā ʻia e hoʻolālā i ka B-cell maturation antigen (BCMA). Ke kū nei kēia lāʻau lapaʻau no kāna ʻano lapaʻau maikaʻi ʻole a me ka ʻike palekana, e hāʻawi ana i kahi manaʻolana hou no nā maʻi me ka relapsed a refractory multiple myeloma (r/rMM). Ua ʻae ʻia e ka National Medical Products Administration (NMPA) ma Iune 30, 2023, ua hōʻike mua ʻo FUCASO i ka kūleʻa nui i nā noi lapaʻau.
Uku Pane Kiekie: Hāʻawi ʻo FUCASO i kahi helu pane holoʻokoʻa (ORR) o 98.9% a me kahi helu pane piha (CR) o 82.4%, ʻoi aku ka kiʻekiʻe ma mua o nā lāʻau lapaʻau ʻē aʻe.
Kalaia mau: Ua hōʻike nā poʻe maʻi i mālama ʻia me FUCASO i ka helu 12-malama Progression-Free Survival (PFS) o 85.5%, e hōʻike ana i ke kala lōʻihi a me ka maikaʻi o ke ola.
Palapala Palekana: Me ka ≥3 grade Cytokine Release Syndrome (CRS) i loaʻa i ka 1% wale nō o nā maʻi a ʻaʻohe hihia i hōʻike ʻia o ≥3 grade Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), hāʻawi ʻo FUCASO i kahi koho mālama palekana i hoʻohālikelike ʻia me nā lāʻau lapaʻau CAR-T ʻē aʻe. .
Kūʻai-Pono: ʻO nā kumukūʻai lapaʻau FUCASO ʻoi aku ka liʻiliʻi ma mua o nā lāʻau lapaʻau like i loaʻa ma ʻAmelika Hui Pū ʻIa, e lilo ia i koho kūpono no kahi ākea o nā maʻi.
Loaʻa honua: Ua hoʻokumuʻo IASO BIO i kahi kikowaena kikowaena lapaʻau ma Kina, hiki ke lawelawe i nā maʻi mai nā wahi a puni o ka honua me nā lawelawe i hoʻohuiʻia mai ka kūkākūkāʻana a hiki i ka mālamaʻana ma hope o ka mālamaʻana.
ʻO ka mea maʻi mua i mālama ʻia me FUCASO ua loaʻa i ʻelima mau makahiki o ke ola ʻole o ka maʻi maʻi maʻi, he mea nui kupaianaha i hoʻohālikelike ʻia me ka median Progression-Free Survival (PFS) o 2.9 mahina wale nō me ka mālama maʻamau. Hōʻike kēia i ka hiki o FUCASO ke hoʻololi i ka ʻāina lapaʻau no ka myeloma lehulehu.