Enhertu(fam-trastuzumab deruxtecan-nxki)(Enhertu; AstraZeneca,Daiichi Sankyo)是一种新型抗体-药物偶联物,具有三个成分:人源化抗HER2免疫球蛋白G1单克隆抗体,其氨基酸序列与曲妥珠单抗相同(Herceptin,Genentech);拓扑异构酶1抑制剂有效载荷;和基于四肽的可裂解接头。 Enhertu在美国被批准用于治疗无法切除或转移...
Learn more about ENHERTU® (fam-trastuzumab deruxtecan-nxki) for several types of cancer. See Full Safety and Boxed WARNINGS for more information.
Learn more about ENHERTU® (fam-trastuzumab deruxtecan-nxki) for several types of cancer. See Full Safety and Boxed WARNINGS for more information.
Locally advanced or metastatic HER2-positive (IHC 3+ or IHC 2+/ISH positive) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen Unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and hav...
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。
2019年12月20日,阿斯利康和第一三共株式会社(Daiichi Sankyo)宣布,美国食品药品管理局FDA加速批准ENHERTU (famr -trastuzumab deruxtecan-nxki)用于治疗无法切除或转移性HER2阳性乳腺癌患者,这些患者之前在转移性环境中接受过两种或两种以上基于...
FDA批准了fam-trastuzumabderuxtecan-nxki (Enhertu)治疗局部晚期或转移性的HER2阳性胃或胃食管腺癌患者,这些患者既往接受过一种曲妥珠单抗为基础的治疗方案。 获批依据: 药物的有效性在一项多中心、开放标签、随机试验中进行了评估,该试验纳入的患者为HER2阳性局部晚期或转移性胃或胃食管腺癌患者,这些患者既往至少接受...
Fam-曲妥珠单抗deruxtecan-nxki是HER2定向的抗体-药物偶联物。该抗体是人源化的抗HER2 IgG1。小分子DXd是拓扑异构酶I通过可裂解的接头与抗体结合的抑制剂。与肿瘤细胞上的HER2结合后,fam-trastuzumab deruxtecan-nxki进行内在化和溶酶体酶裂解胞内接头。释放后,可渗透膜的DXd引起DNA损伤和凋亡细胞死亡。
美国FDA于2019年12月批准第一三共的Enhertu(fam-trastuzumab deruxtecan-nxki,DS-8201a)用于治疗HER2阳性不可切除或转移性乳腺癌成人患者,这些患者在出现转移的情况下已接受过两种或两种以上抗HER2疗法。 Enhertu(DS-8201a)是一种新一代ADC(抗体偶联)药物,通过一种4肽链接子将靶向HER2的人源化单克隆抗体曲妥珠...
Giving azenosertib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or more effective in treating patients with locally advanced, metastatic, or unresectable HER2-positive gastric, gastroesophageal junction, or other solid tumors, compared to just trastuzumab deruxtecan alone. ...