On August 19, 2024, the U.S. Food and Drug Administration (FDA) announced their approval of an exciting new treatment combination: Rybrevant (amivantimab-vmjw) combined with Lazcluze (lazertinib). This treatment combination is meant for people who are newly diagnosed with non-small cell lung cancer (NSCLC) that is either advanced or metastatic (has spread to other parts of the body) and that is positive for EGFR (epidermal growth factor receptor) mutations Exon 19 or 21 L858R. 

Rybrevant (amivantamab-vmjw) is a medication previously approved to help treat people with NSCLC that is positive for EGFR mutations in Exon 20. It is given by IV infusion. Lazcluze (lazertinib) is a type of drug called a tyrosine kinase inhibitor, or TKI, designed to target mutations of EGFR. It is taken as an oral pill. 

This latest approval is based on data from the MARIPOSA trial. This trial compared the combination of Rybrevant (amivantimab-vmjw) and Lazcluze (lazertinib) with: 

  1. The standard of care treatment option of Tagrisso (osimertinib), or
  2. Lazcluze (lazertinib) given on its own as monotherapy (treatment with a single drug or therapy) for people who have advanced NSCLC with mutations of EGFR Exons 19 or 21 L858R that had not yet received treatment.

The study found that the group of people who were given the Rybrevant (amivantimab-vmjw) +Lazcluze (lazertinib) regimen had a significant improvement in progression-free survival (how long the cancer is controlled without spreading/growing), with a difference of 23.7 months compared to 16.6 months in the Tagrisso (osimertinib) monotherapy arm.  

Please speak with your healthcare team for more information about this new combination or to see if it may be a good option for you. If you have questions about treatment, trials, or biomarker testing, our LungMATCH team at support@go2.org or 1-800-298-2436.   

Read the full FDA announcement.