FDA Approves J&J’s RYBREVANT in NSCLC

Johnson & Johnson received approval from the FDA for RYBREVANT (amivantamab-vmjw) in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test. This FDA action converts the May 2021 accelerated approval of RYBREVANT to a full approval based on the confirmatory Phase 3 PAPILLON study.
 
Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases. Alterations in EGFR are the most common actionable driver mutations in NSCLC. 
 
The approval is based on positive results from the randomized, open-label Phase 3 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.1 Results also showed treatment with RYBREVANT plus chemotherapy improved objective response rate (ORR) and progression-free survival (PFS).