On September 19, 2024, Johnson & Johnson made an announcement on the approval of RYBREVANT (amivantamab-vmjw) by the U.S. Food and Drug Administration for the treatment of adult patients with metastatic or locally advanced non-small cell lung cancer (NSCLC) in combination with chemotherapy. The approval is limited to patients who have been therapy with an EGFR tyrosine kinase inhibitor but have progressed in their illness after having epidermal growth factor receptor (EGFR) exon 19 deletions or L858R replacement mutations. The MARIPOSA-2 Phase 3 research results, which showed that combination treatment reduced the risk of disease progression by 52% when compared to chemotherapy alone, and had a median progression-free survival of 6.3 months, served as the basis for this decision.
The approval emphasizes how crucial RYBREVANT is as a primary therapy for individuals with NSCLC who have a high unmet need. With an overall response rate of 53% and proven effectiveness, RYBREVANT gives patients with EGFR-mutated NSCLC fresh hope, especially those who have become resistant to osimertinib or other current therapies. When compared to separate therapies, the combination therapy's safety profile is unchanged. This is RYBREVANT's third FDA clearance in 2024, demonstrating both Johnson & Johnson's dedication to enhancing patient outcomes for patients with this aggressive disease type and the drug's increasing significance in the treatment of lung cancer.
