On September 19, 2024, the U.S. Food and Drug Administration (FDA) issued a new approval for the targeted therapy drug Rybrevant (amivantamab-vmjw) in combination with the existing combination chemotherapy treatment, Paraplatin (carboplatin) + Alimta (pemetrexed). The FDA approved this new combination therapy for people with non-small cell lung cancer (NSCLC) that is advanced/metastatic, is positive for the EGFR (epidermal growth factor receptor) mutations Exon 19 or Exon 21 L858R, and has progressed after prior use of an EGFR targeted therapy. 

Rybrevant (amivantamab-vmjw) is a type of targeted therapy drug called a bi-specific antibody, capable of targeting NSCLC mutations in either EGFR and/or MET. The approval for this therapy is based off the MARIPOSA-2 trial, in which people who had advanced NSCLC with mutations in EGFR Exons 19 or 21 who had progressed on Tagrisso (osimertinib) received either platinum doublet chemotherapy, platinum doublet chemotherapy plus Rybrevant (amivantamab-vmjw), or Rybrevant (amivantamab-vmjw) in combination with other drugs. The study found a 2.1 month improvement in progression-free survival in the chemotherapy plus Rybrevant (amivantamab-vmjw) arm, and showed a higher response rate (53% compared to 29%). 

This combination therapy represents a new treatment option for people with EGFR-positive lung cancer who have progressed on Tagrisso (osimertinib) and are searching for their next steps forward.  

Read the full FDA announcement.