FDA遵循其肿瘤药物咨询委员会的建议,并发出了完整的回复函,拒绝批准131I-omburtamab用于治疗由神经母细胞瘤引起的中枢神经系统和软脑膜转移。——出国看病 根据Y-mAbs Therapeutics的新闻稿,131I-omburtamab是针对已发生中枢神经系统或软脑膜转移的神经母细胞瘤患者的潜在治疗方法,已获得FDA的完整回复函。——出国看...
10月26日,FDA更新了将在本周五召开的ODAC会议信息,委员会将讨论由 Y-mAbs Therapeutics提交的用于注射用131I-omburtamab 溶液治疗儿童神经母细胞瘤的生物制剂许可申请,并就申请人是否提供了足够的证据来支持131I-omburtamab 提高了总体生存率...
Omburtamab I-131 - Y-mAbs Therapeutics NextPrevious Table of Contents At a glance Development Overview Introduction Company agreements Key development milestones Patent information Drug Properties & Chemical Synopsis Biomarker Trial Landscape Development Status ...
MEDULLOBLASTOMACENTRAL nervous system cancerBRAIN tumorsSURVIVAL ratePurpose: Intraventricular compartmental radioimmunotherapy (cRIT) with 131-I-omburtamab is a potential therapy for recurrent primary brain tumors that can seed the thecal space. These patients often previously received external beam ...
OMBLASTYS 131 IOMBURTAMAB YCWD 商标名称 OMBLASTYS 131 IOMBURTAMAB YCWD 国际分类 第42类-网站服务 商标状态 商标注册申请 申请/注册号 67712351 申请日期 2022-10-13 申请人名称(中文) Y型单克隆抗体治疗公司;Y-MABSTHERAPEUTICS,INC 申请人名称(英文) - 申请人地址(中文) 美国纽约州纽约市10169公园...
In this study, we now apply pharmacokinetic modeling to intraOmmaya(131)I-omburtamab (8H9), an antiB7-H3 antibody which has shown promise in RIT of leptomeningeal metastases.Yerrabelli, Rahul S.He, PingFung, Edward K.Kramer, KimZanzonico, Pat B.Humm, John L.Guo, HongfenPandit-Taskar...
OMBLASTYS 131I OMBURTAMAB YCWD 商标名称 OMBLASTYS 131I OMBURTAMAB YCWD 国际分类 第05类-医药 商标状态 商标注册申请 申请/注册号 67710949 申请日期 2022-10-13 申请人名称(中文) Y型单克隆抗体治疗公司;Y-MABSTHERAPEUTICS,INC 申请人名称(英文) - 申请人地址(中文) 美国纽约州纽约市10169公园大道...
Patients initially received 74MBq radioiodinated omburtamab to evaluate dosimetry and biodistribution followed by therapeutic 131 I-omburtamab dose-escalated from 370 to 2960MBq. Patients were monitored clinically and biochemically for toxicity graded using CTCAEv 3.0. Dosimetry was evaluated using ...
Methods: Patients with histologically proven malignancy and metastatic disease to the central nervous system or leptomeninges who met eligibility criteria for 131I-omburtamab therapy underwent immuno-PET imaging with 124I-8H9 followed by 131I-8H9 antibody therapy. Patients were imaged with ...