A marketing authorization application seeking the approval of the combination of lazertinib and amivantamab in the first-line treatment of adult patients with advanced non–small cell lung cancer harboring EGFR mutations has been submitted to the European Medicines Agency.
A supplemental biologics license application and new drug application seeking the approval of amivantamab plus lazertinib as frontline therapy for the treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations have been submitted to the FDA.
The panel reacts to the MARIPOSA trial, which looked at amivantamab, lazertinib, and chemotherapy in the front line in patients with EGFR-mutant non–small cell lung cancer.