Healthcare products company Johnson & Johnson (J&J) (NYSE:JNJ) announced on Tuesday that it has received US Food and Drug Administration (FDA) approval for RYBREVANT (amivantamab-vmjw) plus LAZCLUZE (lazertinib) as a first-line treatment for patients with EGFR-mutated advanced lung cancer.
This combination therapy is the first chemotherapy-free regimen to demonstrate superior progression-free survival compared to osimertinib.
The approval is based on data from the Phase 3 MARIPOSA study, which showed a 30% reduced risk of disease progression or death with RYBREVANT plus LAZCLUZE versus osimertinib. The combination also extended median duration of response by nine months.
Lung cancer is a leading cause of cancer deaths globally. Of patients with EGFR-mutated non-small cell lung cancer (NSCLC), 25-39% never receive second-line therapy due to disease progression and lack of treatment options.
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