Janssen, part of Johnson & Johnson, has submitted an application to the EMA for approval of RYBREVANT (amivantamab) in combination with chemotherapy for treating advanced EGFR-mutated NSCLC after prior therapy failure. The submission is based on Phase 3 MARIPOSA-2 study results, which showed significant improvements in progression-free survival compared to chemotherapy alone. Amivantamab was previously granted conditional marketing authorization by the European Commission in December 2021 for monotherapy treatment of NSCLC with EGFR exon 20 insertion mutations after platinum-based chemotherapy failure.