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27 September 2021: Editorial

Editorial: Global Regulatory Initiatives Deliver Accelerated Approval of the First Bispecific Therapeutic Monoclonal Antibody for Advanced Non-Small Cell Lung Cancer (NSCLC)

Dinah V. Parums *

DOI: 10.12659/MSM.934854

Med Sci Monit 2021; 27:e934854


ABSTRACT: 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.

Keywords: Editorial, EGFR, monoclonal antibody, targeted therapy, Non-Small Cell Lung Cancer, NSCLC, met


The recent regulatory approval of amivantamab-vmjw (Rybrevant®), an EGFR and MET bispecific monoclonal antibody, and the Guardant360® companion diagnostic, herald a new era in targeted therapy for patients with advanced NSCLC. When the COVID-19 pandemic has delayed clinical trials and regulatory approvals in oncology, recent global initiatives developed by the FDA helped accelerate the approval of amivantamab-vmjw (Rybrevant®) for patients with advanced NSCLC and mutations in the EGFR gene exon 20 insertion. Future expansion of recent FDA programs, such as Project Orbis, to include more countries and review more regulatory applications could help offset the delays in approvals associated with the ongoing COVID-19 pandemic.


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Medical Science Monitor eISSN: 1643-3750
Medical Science Monitor eISSN: 1643-3750