The U.S. Food and Drug Administration has granted approval for amivantamab-vmjw as the first treatment to be used in adult patients with non-small cell lung cancer having tumors with certain specific types of genetic mutations, known as the epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

The agency also granted approval for the Guardant360 CDx as a companion diagnostic for the therapy.

The treatment efficacy was determined in a study that included 81 patients with non-small cell lung cancer and EGFR exon 20 insertion mutations. The disease in these patients had progressed on or following platinum-based chemotherapy. All patients received the drug and the overall response rate was found to be 40%. Around 63% of patients had a duration of response of 6 months or more, with the median duration being 11.1 months… (FDA, May 21, 2021)