On March 1, 2024, the U.S. Food and Drug Administration (FDA) approved the drug Rybrevant (amivantamab-vmjw) to be given in combination with carboplatin and pemetrexed in the first lining setting for people with metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 20 mutation. They also announced traditional approval for Rybrevant (amivantamab-vmjw) to be given to people with metastatic non-small cell lung cancer (NSCLC) who are positive for an EGFR exon 20 mutation after they have experienced progression or recurrence while on or after platinum-based chemotherapy.

This decision is based on the results of the PAPILLON trial. The trial assessed the use of Rybrevant (amivantamab-vmjw) in combination with platinum-based chemotherapy in people living with metastatic non-small cell lung cancer who were also positive for an EGFR exon 20 mutation. This study found that platinum-based chemotherapy combined with Rybrevant (amivantamab-vmjw) resulted in improvement in overall survival when compared to platinum-based chemotherapy alone.

The results of this trial and the subsequent approval have provided an exciting new first-line treatment option for people living with advanced/metastatic EGFR exon 20-positive lung cancer. While EGFR mutations are involved in roughly 32% of non-small lung cancer (NSCLC) diagnoses, EGFR exon 20 mutations comprise only 1-12% of these. This alteration tends to be more common in people who are female and those who have not smoked before.

Read the full announcement from the FDA here.