In May 2021, the FDA accelerated the approval of Rybrevant (amivantamab-vmjw; from Janssen/Johnson & Johnson), an intravenous antibody that specifically targets mutations in 2 pathways, the EGFR and MET pathways, for the treatment of adults with non–small-cell lung cancer (NSCLC) that is associated with EGFR exon 20 insertion mutations, as detected by the FDA-approved Guardant360 CDx test. This test was approved on the same day as a companion diagnostic for Rybrevant.
Rybrevant is the first drug approved by the FDA for the treatment of patients with lung cancer linked to EGFR exon 20 insertion mutations. Approximately 2% to 3% of patients with NSCLC have EGFR exon 20 insertion mutations, a group of mutations that causes rapid cell growth (leading to cancer). EGFR exon 20 insertion mutations are the third most common type of EGFR mutations.
“With today’s approval, for the first time, patients with non–small-cell lung cancer with EGFR exon 20 insertion mutations will have a targeted treatment option,” said Julia Beaver, MD, Chief of Medical Oncology of the FDA’s Oncology Center of Excellence.
The FDA approved Rybrevant based on a study of 81 patients with NSCLC and EGFR exon 20 insertion mutations whose disease progressed during or after platinum-based chemotherapy. Overall, 40% of the patients had a response to therapy with Rybrevant, and the average duration of the response was 11.1 months. In 63% of the patients who responded to treatment, the response lasted 6 months or longer.
The most common side effects of Rybrevant include rash, skin infections, muscle and joint pain, shortness of breath, nausea, fatigue, swelling, sores in the mouth, cough, constipation, vomiting, and changes in certain blood tests.
