Posted by Michael Wonder on 20 Aug 2024
FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer
20 August 2024 - On August 19, 2024, the FDA approved lazertinib (Lazcluze, Janssen Biotech) in combination with amivantamab-vmjw (Rybrevant, 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.
Efficacy was evaluated in MARIPOSA, a randomised, active-controlled, multi-centre trial of 1074 patients with exon 19 deletion or exon 21 L858R substitution mutation-positive locally advanced or metastatic NSCLC and no prior systemic therapy for advanced disease.
