Daratumumab (trade name Darzalex) is an anti-cancer drug. It binds to CD38,which multiple myeloma cells overexpress.Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab.
生產(chǎn)方法及用途:
多發(fā)性骨髓瘤新藥
2015年11月16日,美國FDA通過優(yōu)先審評途徑批準了楊森(Janssen)公司的新單克隆抗體藥物Daratumumab上市,商品名為Darzalex。臨床用于曾接受過蛋白酶抑制劑和免疫抑制劑治療后,復發(fā)的多發(fā)性骨髓瘤。該生物工程藥物是抗CD38單克隆抗體,靶向結(jié)合多發(fā)性骨髓瘤細胞表面高度表達的跨膜胞外酶CD38分子,可通過多種機制誘導腫瘤細胞的快速死亡。因為健康細胞和所有骨髓瘤細胞均表達CD38,需要對藥物毒性和治療作用性價比進行充分評估。