Johnson & Johnson Receives FDA Approval for Rybrevant Plus Lazcluze in First-Line NSCLC

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