Johnson & Johnson Receives FDA Approval for Rybrevant in EGFR Exon 20 Insertion NSCLC

Johnson & Johnson today announced that the FDA has approved Rybrevant (amivantamab-vmjw) in combination with carboplatin and pemetrexed as first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. In the Phase 3 PAPILLON trial, Rybrevant plus chemotherapy demonstrated a statistically significant improvement in progression-free survival compared to chemotherapy alone. The median PFS was 11.4 months for Rybrevant plus chemotherapy versus 6.7 months for chemotherapy alone. This approval provides patients with EGFR exon 20 insertion NSCLC a new first-line treatment option.