美国食品和药物管理局批准Vyloy (zolbetuximab-clzb) 用于先进的HER2- 阴性胃癌和CLDN18. 2阳性瘤的第一线治疗, FDA approves Vyloy (zolbetuximab-clzb) for first-line treatment of advanced HER2-negative gastric cancer with CLDN18.2 positive tumors, with Roche'
美国食品和药物管理局批准Vyloy (zolbetuximab- clzb) 用于治疗晚期HER2- 阴性胃或胃食道结腺癌的成年患者,并具有CLDN18. 2阳性瘤. The FDA has approved Vyloy (zolbetuximab-clzb) for treating adults with advanced HER2-negative gastric or gastroesophageal junction adenocarcinoma with CLDN18.2 positive tumors. 这种用于化疗的第一线疗法表明,临床试验中的无进展存活率有所改善。 This first-line therapy, used with chemotherapy, showed improved progression-free survival in clinical trials. 此外,Roche的VENTANA§N18(43-14A)RxDx Assay被批准为一项辅助诊断,以确定符合资格的病人,标志着有针对性的癌症治疗迈出了一大步。 Additionally, Roche’s VENTANA CLDN18 (43-14A) RxDx Assay was approved as a companion diagnostic to identify eligible patients, marking a significant step in targeted cancer treatment.