FDA Approves Targeted Therapy Amivantamab-vmjw for Subset of NSCLC
Posted: Monday, May 24, 2021
On May 21, the U.S. Food and Drug Administration (FDA) approved the use of the targeted therapy amivantamab-vmjw (Rybrevant) for adults with non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Also, the FDA simultaneously approved the companion diagnostic Guardant360 CDx for amivantamab.
The FDA approval was based on a recent study investigating the overall response rate of amivantamab in 81 patients with NSCLC and EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy. Results showed a 40% overall response rate. The median duration of response was 11.1 months, with 63% of patients experiencing a duration of response of 6 months or more.
Common side effects reported with amivantamab included rash, infusion-related reactions, skin infections around the fingernails or toenails, muscle and joint pain, shortness of breath, nausea, fatigue, swelling in the lower legs or hands or face, sores in the mouth, cough, constipation, vomiting, and changes in certain blood tests.