Johnson & Johnson 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.
Yuhan Corporation in-licensed lazertinib in 2015 from Genosco Inc. In 2018, Jassen Biotech Inc., based on results from the phase 1/2 clinical trial conducted in Korea, entered a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE™ (lazertinib, marketed as LACLAZA in Korea).
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.
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.