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FDA Approves J&J’s RYBREVANT in NSCLC

Phase 3 study demonstrates reduced the risk of disease progression or death by 61 percent versus chemotherapy alone.

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By: Kristin Brooks

Managing Editor, Contract Pharma

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, lun...

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