FDA approves Lazcluze with Rybrevant for NSCLC

The US Food and Drug Administration (FDA) has approved Lazcluze (lazertinib) in combination with Rybrevant (amivantamab-vmjw), from Janssen Biotech, for the first-line treatment of 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.

Janssen, a subsidiary of US healthcare giant Johnson & Johnson (NYSE: JNJ), noted that, 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.

The company explained that 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.