The U.S. Food and Drug Administration (FDA) updated the label for amivantamab (Rybrevant) on 2025-11-11. The revision includes a new indication for amivantamab in combination with 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 20 insertion mutations.
Background
Amivantamab is a bispecific antibody that targets both the epidermal growth factor (EGF) receptor and the mesenchymal-epithelial transition (MET) receptor. The updated label specifies its use in combination with lazertinib for patients with locally advanced or metastatic non-small cell lung cancer who harbor EGFR exon 20 insertion mutations. This patient population often faces limited treatment options, making targeted therapies crucial.
What this means
This label revision provides a new first-line treatment option for adult patients diagnosed with locally advanced or metastatic non-small cell lung cancer driven by EGFR exon 20 insertion mutations. The combination of amivantamab with lazertinib offers clinicians an additional therapeutic strategy for a challenging form of NSCLC, potentially improving outcomes for eligible patients who previously had fewer initial treatment choices.
Source
The information regarding this label revision was obtained from the U.S. Food and Drug Administration (FDA) via DailyMed. The updated indication and usage for Rybrevant were made effective on 2025-11-11, as detailed on dailymed.nlm.nih.gov.