FDA approval history for Lutathera (lutetium Lu 177 dotatate) used to treat Gastroenteropancreatic Neuroendocrine Tumors. Supplied by Advanced Accelerator Applications S.A.
FDA approval was based on pivotal Phase III VISION trial, where patients with pre-treated PSMA-positive mCRPC who received Pluvicto plus standard of care had a statistically significant reduction in risk of death1; both alternate primary endpoints of overall survival and radio...
美国FDA于2018年1月26日批准Advanced Accelerator Applications USA公司的Lutetium Lu 177Dotatate(商品名:Lutathera)注射液上市,用于治疗生长抑素受体阳性的胃肠胰腺神经内分泌肿瘤.本药可与生长抑素受体结合,且对生长抑素受体2(SSRT2)亲和力最高. 展开 关键词: FDA 生长抑素受体 Lutetium Lu 177 Dotatate 年份:...
FDA approval was based on pivotal Phase III VISION trial, where patients with pre-treated PSMA-positive mCRPC who received Pluvicto plus standard of care had a statistically significant reduction in risk of death1; both alternate primary endpoints of overall survival and radiographic progression free ...
LUTATHERA (lutetium Lu 177 dotatate) 370 MBq/mL (10 mCi/mL) Injection is a sterile, clear, colorless to slightly yellow solution for intravenous use. Each single-dose vial contains acetic acid (0.48 mg/mL), sodium acetate (0.66 mg/mL), gentisic acid (0.63 mg/mL), sodium hydroxide (0.65...
Jonathan Strosberg, MD, section head of the Neuroendocrine Tumor Program and vice president of Medical Oncology at the Moffitt Cancer Center, discusses some of the adverse events patients experienced during the phase 3 trial assessing lutetium Lu 177 dotatate for midgut neuroe...
Curium will work closely with the FDA through the review and approval process. Curium looks forward to potential approval of its Lutetium Lu 177 Dotatate formulation so that more patients suffering from GEP-NETS may have access to the potential benefits of...
Of deceased patients, median survival from C1 to death was 4.8 months (range 0.4-11.7).Conclusions:To our knowledge, this is the largest multicenter retrospective analysis of a racially diverse cohort of mCRPC pts receiving SOC Lu177-Plu following FDA approval in the US. PSA decline, median ...
delivers local radiation via beta particle emission, gained FDA approval for gastroenteropancreatic neuroendocrine tumors, a disease characterized by SST2A ... MA Lazow,AT Trout,S Sara,... - Neuro-Oncology 被引量: 0发表: 2024年 Non-Functioning Pancreatic Neuroendocrine Tumors Non-functioning pancrea...
LUTATHERA (lutetium Lu 177 dotatate) 370 MBq/mL (10 mCi/mL) Injection is a sterile, clear, colorless to slightly yellow solution for intravenous use. Each single-dose vial contains acetic acid (0.48 mg/mL), sodium acetate (0.66 mg/mL), gentisic acid (0.63 mg/mL), sodium hydroxide (0.65...