RARITAN, N.J. - Johnson & Johnson (NYSE: NYSE:JNJ) has received approval from the U.S. Food and Drug Administration (FDA) for RYBREVANT® (amivantamab-vmjw) combined with chemotherapy for the initial treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. This approval, announced today, transitions the May 2021 accelerated approval of RYBREVANT® to full approval, following the Phase 3 PAPILLON study results.
The PAPILLON study showed a 61 percent reduction in disease progression or death risk when using RYBREVANT® with chemotherapy compared to chemotherapy alone. The National Comprehensive Cancer Network® (NCCN®) has updated its guidelines to recommend this combination as a preferred first-line regimen for the specified patient group.
Lung cancer remains one of the most common cancers worldwide, with NSCLC accounting for the majority of cases. EGFR mutations are prevalent in NSCLC, and patients with the EGFR exon 20 insertion mutation typically have poorer prognoses and limited benefits from existing treatments.
The FDA's decision is based on the PAPILLON study's evidence of improved progression-free survival and objective response rate with RYBREVANT® plus chemotherapy. Advocacy groups have welcomed this development, highlighting the potential lifeline it offers to patients and families affected by this type of lung cancer.
The approval of RYBREVANT® plus chemotherapy marks the first targeted approach approved for first-line treatment of NSCLC with this specific EGFR mutation. Johnson & Johnson aims to further advance its lung cancer treatment portfolio based on this milestone.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.