Johnson & Johnson Receives FDA Approval for Rybrevant Plus Lazertinib in EGFR-Mutated NSCLC

Johnson & Johnson today announced that the FDA has approved Rybrevant (amivantamab-vmjw) in combination with lazertinib for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations. In the Phase 3 MARIPOSA trial, the combination demonstrated a statistically significant improvement in progression-free survival compared to osimertinib. The median PFS was 23.7 months for Rybrevant plus lazertinib versus 16.6 months for osimertinib. This approval establishes a new first-line treatment option for patients with EGFR-mutated NSCLC.