Rybrevant (amivantamab-vmjw) in combination with chemotherapy is the first FDA approved therapy for first-line treatment of patients with non-small cell lung cancer with EGFR exon 20 insertion mutations-- Johnson & Johnson.

This FDA action converts the May 2021 accelerated approval of Rybrevant to a full approval based on the confirmatory Phase III PAPILLON study.

"When aiming for the best possible treatment outcomes, a targeted approach should be used in the first line for patients with EGFR exon 20 insertion mutations, as this is a commonly applied practice for patients with NSCLC harboring other molecular driver alterations,” said Joshua K. Sabari, M.D., an oncologist at NYU Langone’s Perlmutter Cancer Center and study investigator. “The results observed in the PAPILLON study showed significant improvement in progression-free survival, supporting the use of this regimen as the potential standard-of-care in the first-line treatment of these patients.”

The FDA approval is based on positive results from the randomized, open-label Phase III PAPILLON study , which showed Rybrevant plus chemotherapy resulted in a 61 percent reduction in the risk of disease progression or death compared to chemotherapy alone. Results also showed treatment with Rybrevant plus chemotherapy improved objective response rate (ORR) and progression-free survival (PFS). Based on PAPILLON data, the National Comprehensive Cancer Network (NCCN ) updated its’ NCCN Clinical Practice Guidelines (NCCN Guidelines) to include a category 1 recommendation for amivantamab-vmjw (Rybrevant) plus chemotherapy as a preferred first-line therapy for patients with NSCLC with EGFR exon 20 insertion mutations.