J&J’s Chemotherapy-Free NSCLC Treatment Gets FDA Approval

The FDA has approved Johnson & Johnson’s 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.
 
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.
 
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.
 
The FDA approval is based on positive results from the Phase 3 MARIPOSA study, which showed RYBREVANT plus LAZCLUZE reduced the risk of disease progression or death by 30 percent compared to osimertinib (median progression-free survival [PFS]: 23.7 months versus 16.6 months) in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations. The median duration of response (DOR) was nine months longer with RYBREVANT plus LAZCLUZE versus osimertinib (25.8 months versus 16.7 months), a secondary endpoint of the study.
 
“Building on more than three decades of oncology innovation, we are uniquely positioned to build best-in-class treatments where survival rates have remained stagnant for years,” said Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson. “RYBREVANT plus LAZCLUZE establishes a new benchmark in the advanced first-line setting, and we look forward to bringing this new chemotherapy-free treatment regimen to patients.”