Johnson & Johnson has introduced RYBREVANT® (amivantamab-vmjw) as a groundbreaking therapy for the initial treatment of individuals diagnosed with non-small cell lung cancer (NSCLC) harbouring EGFR exon 20 insertion mutations.
RYBREVANT® is a fully-human bispecific antibody that targets EGFR and MET, featuring immune cell-directing capabilities. It has gained approval in various markets, including the U.S. and Europe, as a monotherapy for adult patients with locally advanced or metastatic NSCLC possessing EGFR exon 20 insertion mutations, as identified by an FDA-endorsed test.
This approval follows positive results from the Phase 3 PAPILLON study, which showcased RYBREVANT® in combination with chemotherapy substantially reducing the risk of disease progression or mortality by 61 percent compared to chemotherapy alone in previously untreated NSCLC patients with EGFR exon 20 insertion mutations.
NSCLC accounts for the majority of lung cancer cases worldwide, with EGFR alterations being the most common actionable driver mutations.
Clinical evidence indicates that patients with EGFR exon 20 insertion mutations typically derive limited benefits from existing third-generation EGFR tyrosine kinase inhibitors and chemotherapy.