J&J’s chemotherapy-free drug combo wins FDA nod for advanced lung cancer

Johnson & Johnson’s (NYSE:JNJ) chemotherapy-free drug combination has been cleared in the U.S. for the first-line treatment of patients with EGFR-mutated advanced lung cancer.

The FDA approval is based on positive results from the Phase 3 MARIPOSA study, which showed Rybrevant plus Lazcluze reduced the risk of disease progression or death by 30% compared to osimertini (median progression-free survival [PFS]: 23.7 months versus 16.6 months) in the first-line treatment of patients with EGFR-mutated metastatic non-small cell lung cancer (NSCLC).

The median duration of response was nine months longer with Rybrevant plus Lazcluze versus osimertinib (25.8 months versus 16.7 months), a secondary endpoint of the study.

The drug combo becomes the first and only chemotherapy-free regimen showing superior superiority versus osimertinib approved for the first-line treatment of patients with EGFR-mutated NSCLC.