Healthcare Aug 17, 2021 07:42 PM (GMT+8) · EqualOcean
On August 17, yiouda health learned that Kaiser of Baiji Shenzhou ®( Datuximab β, QARZIBA ®) It has been approved by the State Drug Administration (nmpa) for the treatment of high-risk neuroblastoma patients aged 12 months and above, and patients with recurrent or refractory neuroblastoma with or without residual lesions. At present, the drug is the first targeted immunotherapy drug approved for the treatment of neuroblastoma in China. Neuroblastoma originated from adrenal medulla or paravertebral sympathetic nervous system. It is an extracranial solid tumor prone to children. It accounts for about 8% ~ 10% of malignant tumors in children, but the mortality accounts for 15%. Neuroblastoma is often called "the king of children's tumors" because of its high degree of malignancy, rapid disease progress and difficult treatment. According to the previous apn311-302 study, kaizebai ® The 5-year event free survival rate of patients with high-risk neuroblastoma was 57%, which was significantly improved by 15% (P < 0.001); The 5-year overall survival rate was 64%, significantly increased by 14% (P < 0.001); At the same time, the risk of disease recurrence was significantly reduced by 16% (P < 0.001). Apn311-202 V3 research shows that Kaiser ® The objective remission rate (ORR) of recurrent or refractory neuroblastoma was about 50%, the 3-year event free survival rate was 57%, and the 3-year overall survival rate was 71%.