FDA 加速批准第一三共$阿斯利康(AZN)$Enhertu(fam-trastuzumab deruxtecan-nxki)用于治疗不可切除或转移性 HER2 阳性实体瘤#ADC创新药物# 2024年4月5日,美国食品和药物管理局加速批准fam-trastuzumab deruxtecan-nxki(Enhertu,第一三共公司)用于既往接受过系统治疗且无满意替代治疗方案的不可切除或转移性HER2阳性...
ENHERTU (6.4mg/kg) is approved in more than 65 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based...
2022年8月5日,FDA正式批准 fam-trastuzumab deruxtecan-nxki(Enhertu)用于治疗既往接受过化疗的不可切除或转移性、或完成辅助化疗期间或六个月内出现疾病复发的HER2低表达(IHC 1+ 或 IHC2+/ISH-)乳腺癌成年患者。 ▲参考资料6 至此,Enhertu成为了全球首个被各大权威机构和指南推荐用于治疗HER2低表达乳腺癌的H...
Enhertu新适应症再获FDA批准 8月11日,FDA加速批准第一三共Enhertu(fam-trastuzumab deruxtecan-nxki ,DS-8201)新适应症,用于之前接受过系统治疗的无法切除或转移性HER2突变阳性成人非小细胞肺癌(NSCLC)患者。这是FDA批准的第一个用于HER2突变阳性非小细胞肺癌的药物。 FDA同时批准了 Life Technologies公司的Oncomine...
美国食品和药物管理局FDA宣布,加速批准第一三共(Daiichi Sankyo)和阿斯利康(AstraZeneca)共同开发,靶向HER2的抗体偶联药物(ADC)Enhertu(fam-trastuzumab deruxtecan-nxki,曾用名DS-8201)上市,治疗无法切除或转移性HER2阳性乳腺癌患者。这些患者在转移性情况下接受过2种(包括曲妥珠单抗,trastuzumab)以上抗HER2疗法的治疗。
ENHERTU (6.4mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based o...
ENHERTU (6.4mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior ...
Fam-trastuzumab deruxtecan、T-DXd、Trastuzumab deruxtecan + [13] 靶点 HER2 作用机制 HER2拮抗剂(受体蛋白酪氨酸激酶 erbB-2拮抗剂)、ADCC(抗体依赖的细胞毒作用) 治疗领域 肿瘤消化系统疾病呼吸系统疾病+ [6] 在研适应症 HR阳性/HER2低表达乳腺癌HER2阳性胃腺癌HR阳性/HER2阳性乳腺癌+ [56] ...
AstraZeneca and Daiichi Sankyo’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ ...
AstraZeneca and Daiichi Sankyo’s Results from the primary analysis of the DESTINY-Lung02 Phase II trial showed ENHERTU® (fam-trastuzumab deruxtecan-nxki) continued to demonstrate strong and durable tumor re...