Johnson & Johnson Secures FDA Nod for New Lung Cancer Therapy, RYBREVANT and LAZCLUZE

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Johnson & Johnson (NYSE:JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.1,2

With this milestone, RYBREVANT® plus LAZCLUZE™ becomes the first and only multitargeted, chemotherapy-free combination regimen with demonstrated superiority versus osimertinib approved for the first-line treatment of patients with EGFR-mutated NSCLC.1,2 RYBREVANT® is an EGFR- and MET*-directed bispecific antibody that engages the immune system, and LAZCLUZE™ is a highly selective, brain-penetrant, third-generation oral EGFR TKI**. RYBREVANT® plus LAZCLUZE™ is the only multitargeted regimen targeting both the common EGFR mutations directly.1,2