Johnson & Johnson's RYBREVANT® Receives FDA Approval for First-Line Treatment of NSCLC with EGFR Exon 20 Insertion Mutations

Johnson & Johnson announced the FDA approval of RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy as the first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This approval, based on the Phase 3 PAPILLON study, marks a conversion of the accelerated approval granted in May 2021. Dr. Joshua K. Sabari, an oncologist and study investigator, emphasized the importance of targeted treatment for patients with these mutations, citing significant improvement in progression-free survival observed in the study. EGFR exon 20 insertion mutations are associated with limited benefits from current treatments and poorer prognosis compared to other EGFR mutations in NSCLC.