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 Lazcluze (lazertinib) as first-line treatment for adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. In the Phase 3 MARIPOSA trial, amivantamab plus lazertinib demonstrated superior progression-free survival versus osimertinib, with a hazard ratio of 0.70. This approval establishes a new first-line standard of care for EGFR-mutated NSCLC and represents a significant advancement over existing EGFR-targeted therapies.