Ma ʻAukake 24, 2022, ua ʻāpono ka US Food and Drug Administration (FDA) i ka ibrutinib no ka mālama ʻana i nā maʻi pediatric ma mua o 1 makahiki me ka maʻi graft-versus-host mau (cGVHD) e loaʻa ana ma hope o ka hāʻule ʻana o ka lāʻau lapaʻau 1- a i ʻole multi-line systemic. ʻO ka hōʻailona i ʻāpono ʻia no nā maʻi pediatric, me ka helu pane holoʻokoʻa o 60% ma ka pule 25, a ʻo nā ʻano lāʻau lapaʻau e komo pū me nā capsules, nā papa a me nā hoʻokuʻu waha.
ʻO Ibrutinib, kahi mea hoʻopaʻa BTK i hoʻomohala pū ʻia e Pharmacyclics/Johnson & Johnson, he mea hoʻopaʻa kinase i ʻae mua ʻia no ka mālama ʻana i ka leukemia lymphocytic mau loa a me ka lymphoma cell a me nā maʻi ʻē aʻe.
Ke kālele nei ʻo Suntech i ka hoʻomohala ʻana a me ka hana ʻana i nā mea waena lāʻau lapaʻau a me nā API me ka hoʻohana ʻana i ka ʻenehana ʻōmaʻomaʻo. I kēia manawa, ua hoʻomohala kā mākou hui i ʻekolu mau huahana waena o ibrutinib me C AS: 143900-44-1, C AS: 330792-70-6, C AS: 330786-24-8, a ua kūʻai ʻia aku nā mea a pau ma nā hale hana GMP. I waena o lākou, ua hana ʻia ka waena o C AS: 143900-44-1 e ka ʻenehana kemika-enzymatic, nona nā pono o ka palekana kaiapuni ʻōmaʻomaʻo, ke kumu kūʻai haʻahaʻa a me ke kūlana kiʻekiʻe. Welina mai e kūkākūkā a hana pū!
Ka manawa hoʻouna: Nov-04-2022