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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 combination of amivantamab and lazertinib reduced the risk of disease progression or death by 30% compared with osimertinib alone as frontline therapy for patients with advanced non–small cell lung cancer harboring classical EGFR sensitizing mutations. ....
First-line treatment with the combination of amivantamab and lazertinib resulted in a statistically significant and clinically meaningful improvement in progression-free survival compared with osimertinib in patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR mutations. ....
A supplemental biologics license application seeking the expanded approval of amivantamab-vmjw in combination with carboplatin plus pemetrexed for use in the frontline treatment of patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations has been submitted to the FDA. ....