Science Editor, Medical Science Monitor, International Scientific Information, Inc., Melville, NY, USA.
Med Sci Monit. 2021 Sep 27;27:e934854. doi: 10.12659/MSM.934854.
The coronavirus disease 2019 (COVID-19) pandemic has affected the number of completed clinical trials, particularly in oncology. Between 80-85% of all lung cancers are non-small cell lung cancer (NSCLC), and of these, between 2-3% have an EGFR exon 20 insertion, which is associated with increased cell proliferation, metastasis, and a lack of response to chemotherapy and epidermal growth factor receptor (EGFR) inhibitors. Until this year, there were no available targeted therapies for advanced NSCLC with this genetic subtype. However, in May 2021, the US Food and Drug Administration (FDA) granted accelerated approval for amivantamab-vmjw (Rybrevant®), a bispecific monoclonal antibody, targeting activating and resistant EGFR and MET mutations and amplifications. This FDA approval was for adult patients with locally advanced metastatic NSCLC, with disease progression on or following platinum-based chemotherapy. The FDA also approved the Guardant360® companion diagnostic, a next-generation sequencing platform for circulating tumor DNA (ctDNA), which is a liquid biopsy assay. In 2019, Project Orbis was launched by the FDA Oncology Center of Excellence as a global collaborative review program to facilitate rapid global access for patients to innovative cancer therapies. This Editorial aims to highlight how global regulatory initiatives from the FDA have delivered accelerated approval of the first bispecific therapeutic monoclonal antibody, amivantamab-vmjw (Rybrevant®), and a companion diagnostic for patients with advanced NSCLC with an EGFR exon 20 insertion.
新型冠状病毒病 2019（COVID-19）大流行影响了已完成临床试验的数量，尤其是在肿瘤学领域。所有肺癌中约有 80-85%是非小细胞肺癌（NSCLC），其中 2-3%存在 EGFR 外显子 20 插入，这与细胞增殖增加、转移以及对化疗和表皮生长因子受体（EGFR）抑制剂无反应有关。直到今年，这种遗传亚型的晚期 NSCLC 仍没有可用的靶向治疗方法。然而，2021 年 5 月，美国食品和药物管理局（FDA）加速批准了针对激活和耐药性 EGFR 和 MET 突变和扩增的双特异性单克隆抗体 amivantamab-vmjw（Rybrevant®），用于治疗局部晚期转移性 NSCLC 成年患者，这些患者在铂类化疗期间或之后疾病进展。FDA 还批准了 Guardant360®伴随诊断，这是一种用于循环肿瘤 DNA（ctDNA）的下一代测序平台，也是一种液体活检检测方法。2019 年，FDA 肿瘤卓越中心发起了“项目奥比斯”（Project Orbis），作为一项全球性合作审查计划，以促进全球患者快速获得创新癌症疗法。本社论旨在强调 FDA 的全球监管举措如何加速批准首个双特异性治疗性单克隆抗体 amivantamab-vmjw（Rybrevant®），以及用于 EGFR 外显子 20 插入的晚期 NSCLC 患者的伴随诊断。
